Efficacy and safety of probiotics in irritable bowel syndrome: A systematic review and meta-analysis.

BACKGROUND: Irritable bowel syndrome (IBS) is a common gastrointestinal disease characterized by abdominal pain, distension, and altered bowel habits. Probiotics may alleviate IBS symptoms, but clinical trials remain conflicting. AIMS: To conduct a systematic review and meta-analysis of clinical trials to evaluate the efficacy and safety of probiotics for IBS patients. METHODS: We searched relevant trials in PubMed, Web of Science, Embase, Cochrane Library, and Google Scholar from 2000 to June 2023. Standardized mean difference (SMD) and 95% confidence interval (CI) were calculated for continuous outcomes. A risk ratio (RR) and a 95% CI were calculated for dichotomous outcomes. RESULTS: A total of 20 studies involving 3011 patients were obtained. The results demonstrated that probiotics are more effective than placebo in reducing global IBS symptoms improvement rate (RR = 1.401, 95% CI 1.182-1.662, P < 0.001) and quality of life scores (SMD = 0.286, 95% CI = 0.154-0.418, P < 0.001). Subgroup analyses showed that a shorter treatment time (less than eight weeks) could reduce distension scores (SMD = 0.197, 95% CI = 0.038-0.356, P = 0.015). High doses (daily dose of probiotics ≥ 10ˆ10) or multiple strains of probiotics exhibit beneficial effects on abdominal pain (SMD = 0.412, 95% CI = 0.112-0.711, P = 0.007; SMD = 0.590, 95% CI = 0.050-1.129, P = 0.032; respectively). However, there was no significant benefit on global symptom scores (SMD = 0.387, 95% CI 0.122 to 0.653, P = 0.004) with statistically high inter-study heterogeneity (I2 = 91.9%, P < 0.001). Furthermore, there was no significant inter-group difference in terms of adverse events frequency (RR = 0.997, 95% CI 0.845-1.177, P = 0.973). CONCLUSION: Probiotics are effective and safe for IBS patients. High doses or multiple probiotic strains seem preferable, but definite conclusions are challenging due to the high heterogeneity. Large-scale, well-designed, and rigorous trials are needed to confirm their effectiveness.

Safety and Effectiveness of Probiotics in Preterm Infants with Necrotizing Enterocolitis.

Although necrotizing enterocolitis is a leading cause of morbidity and mortality among preterm infants, its underlying pathophysiology is not fully understood. Gut dysbiosis, an imbalance between commensal and pathogenic microbes, in the preterm infant is likely a major contributor to the development of necrotizing enterocolitis. In this review, we will discuss the increasing use of probiotics in the NICU, an intervention aimed to mitigate alterations in the gut microbiome. We will review the existing evidence regarding the safety and effectiveness of probiotics, and their potential to reduce rates of necrotizing enterocolitis in preterm infants.

Safety and Effectiveness of Probiotics in Preterm Infants with Necrotizing Enterocolitis.

Although necrotizing enterocolitis is a leading cause of morbidity and mortality among preterm infants, its underlying pathophysiology is not fully understood. Gut dysbiosis, an imbalance between commensal and pathogenic microbes, in the preterm infant is likely a major contributor to the development of necrotizing enterocolitis. In this review, we will discuss the increasing use of probiotics in the NICU, an intervention aimed to mitigate alterations in the gut microbiome. We will review the existing evidence regarding the safety and effectiveness of probiotics, and their potential to reduce rates of necrotizing enterocolitis in preterm infants.

Clostridium butyricum Bacteremia Associated with Probiotic Use, Japan.

Clostridium butyricum, a probiotic commonly prescribed in Asia, most notably as MIYA-BM (Miyarisan Pharmaceutical Co., Ltd.; https://www.miyarisan.com), occasionally leads to bacteremia. The prevalence and characteristics of C. butyricum bacteremia and its bacteriologic and genetic underpinnings remain unknown. We retrospectively investigated patients admitted to Osaka University Hospital during September 2011-February 2023. Whole-genome sequencing revealed 5 (0.08%) cases of C. butyricum bacteremia among 6,576 case-patients who had blood cultures positive for any bacteria. Four patients consumed MIYA-BM, and 1 patient consumed a different C. butyricum-containing probiotic. Most patients had compromised immune systems, and common symptoms included fever and abdominal distress. One patient died of nonocclusive mesenteric ischemia. Sequencing results confirmed that all identified C. butyricum bacteremia strains were probiotic derivatives. Our findings underscore the risk for bacteremia resulting from probiotic use, especially in hospitalized patients, necessitating judicious prescription practices.

Efficacy and safety of a cream containing panthenol, prebiotics, and probiotic lysate for improving sensitive skin symptoms.

BACKGROUND: Sensitive skin is a common condition affecting a significant proportion of the population, and there is a growing demand for effective and safe management. AIM: To evaluate the efficacy and safety of a cream containing panthenol, prebiotics, and probiotic lysate as an optimal care for facial sensitive skin. METHODS: A total of 110 participants (64 in group A and 46 in group B) with facial sensitive skin applied the cream twice daily for 28 days. Group A evaluated their sensitive skin, product efficacy, and product use experience at D0 (15 min), D1, D14, and D28. In group B, skin barrier function-related indicators were measured at baseline and on D1, D7, D14, and D28. Dermatologists evaluated tolerance for all participants. RESULTS: After 28 days of use, in group A, 100% of participants reported mildness and comfort with product use. Participants demonstrated significant improvements in skin barrier function-related indicators, including increased stratum corneum moisture content, reduced erythema index, elevated sebum content, decreased trans-epidermal water loss, and diminished skin redness parameter a* value (all p < 0.05). Dermatologist evaluations revealed excellent tolerance among all participants. CONCLUSION: The panthenol-enriched cream with prebiotics and probiotic lysate exhibited substantial clinical efficacy in ameliorating facial sensitive skin conditions, coupled with a high safety profile.

Comparative efficacy and tolerability of probiotic, prebiotic, and synbiotic formulations for adult patients with mild-moderate ulcerative colitis in an adjunctive therapy: A network meta-analysis.

BACKGROUND & AIMS: Probiotics, prebiotics, and synbiotics (PPS) have been widely used as adjuvant treatments in patients with ulcerative colitis (UC) in recent years. However, the most effective formulations of PPS have yet to be identified. We thus aimed to compare the efficacy and tolerability of different PPS formulations for mild-moderate UC. METHODS: We searched PubMed, Embase, Web of Science, and Cochrane CENTRAL from inception to June 24, 2023 for double-blind randomized controlled trials. We used a frequentist approach in random-effects models for network meta-analysis and the Grading of Recommendations Assessment, Development, and Evaluation approach to evaluate the certainty of evidence. RESULTS: We analysed data from 20 trials involving 1153 patients. The combinations of specific strains of Lactobacillus and Bifidobacterium (CLB) (odds ratio (OR), 3.85; 95 % confidence interval (CI), 1.40-10.60; low certainty) and combinations of specific strains of Lactobacillus, Bifidobacterium, and Streptococcus (CLBS) (OR, 2.20; 95 % CI, 1.47-3.28; low certainty) significantly increased the clinical remission rate in intention-to-treat analysis (ITT) when compared to placebo. Similarly, compared with placebo, the two combinations significantly reduced clinical activity scores (standardized mean difference (SMD), -1.17 (95 % CI, -1.68 to -0.65), low certainty; and SMD, -1.33 (95 % CI, -1.81 to -0.86), low certainty, respectively). Hierarchical cluster analyses showed the two combinations formed clusters with high efficacy (clinical remission in ITT and clinical activity score) and tolerability (withdrawal due to worsening symptoms) within 12 weeks. CONCLUSION: In this systematic review, we found CLB and CLBS demonstrated a clinical benefit in adjuvant treatments, with a comparable tolerability and safety profile to placebo. Further trials are needed. TRIAL REGISTRATION NUMBER: CRD42022344905.

Efficacy and safety of probiotics, prebiotics, and synbiotics for the prevention of colorectal cancer and precancerous lesion in high-risk populations: A systematic review and meta-analysis of randomized controlled trials.

OBJECTIVES: Colorectal cancer (CRC) is highly prevalent worldwide and is a leading cause of cancer-related death. Probiotics, prebiotics, and synbiotics have recently attracted attention as preventive measures against colorectal neoplasms. We aimed to analyze the findings of randomized controlled trials (RCTs) on the effects of probiotics, prebiotics, and synbiotics in patients at a high risk of CRC, outlining the challenges and future prospects of using probiotics to prevent colorectal tumors and providing evidence for clinical physicians in particular. METHODS: PubMed, EMBASE, and the Cochrane Library databases were searched for relevant studies published up to January 7, 2022. RCTs conducted on populations with a high risk of CRC who received probiotics, prebiotics or synbiotics in comparison with placebo, candidate agent or no treatment were included. The primary outcome was the incidence or recurrence of any colorectal neoplasms. Additional outcomes included their effects on the diversity of gut microbiota and relevant inflammatory biomarkers. Safety outcomes were also analyzed. Two authors independently screened and selected studies based on pre-specified eligible criteria, performed data extraction and risk-of-bias assessment independently. RESULTS: Nine RCTs were included in the systematic review and meta-analysis. Probiotic supplementation significantly reduced adenoma incidence, but no significant benefit was observed in CRC incidence. Additionally, probiotics modulated gut microbiota and inflammatory biomarkers. CONCLUSION: Probiotics may have beneficial effects in the prevention of CRC. More RCTs with larger sample sizes are warranted to further confirm these findings.

Septicemia due to Bacillus clausii after the use of probiotics. A complication to keep in mind. / Septicemia por Bacillus clausii posterior al uso de probióticos. Una complicación para tener presente.

Probiotics are live microorganisms that benefit the host in different clinical situations. Bacillus clausii is one of the most frequently used, but it is not without risk. To date, there are few reports of complications secondary to this agent in pediatric patients. OBJECTIVE: To describe the case of an infant who developed after treatment sepsis due to Bacillus clausii. CLINICAL CASE: A 4-month-old female infant of indigenous ethnicity, from a rural area in the interior of Panama, 3 hours away from the nearest health sub-center by canoe, and with protein-calorie malnutrition, presented with acute diarrhea and moderate-severe dehydration, receiving Enterogermina as part of the initial treatment. She was transferred to a tertiary hospital, where she arrived with impaired consciousness, respiratory distress, and signs of shock. The initial blood culture reported growth of methicillin-resistant Staphylococcus aureus (MRSA), the gastrointestinal panel was positive for Clostridiodes difficile, and later serial blood cultures of peripheral blood and central venous catheter confirmed growth of Bacillus clausii. With a torpid evolution and resistance to multiple antibiotic schemes, she died due to multisystem organ failure twelve days after admission. CONCLUSIONS: The use of probiotics as concomitant treatment in patients with some degree of immunosuppression should be administered with caution, considering the presence of risk criteria for complications such as malnutrition or intestinal epithelial damage due to severe diarrhea since they predispose to the development of bacteremia and/or sepsis.

Efficacy and Safety of Probiotics in Geriatric Patients with Constipation: Systematic Review and Meta-Analysis.

BACKGROUND: Probiotics may be an effective alternative to traditional drug therapy for constipation in the elderly. OBJECTIVE: To assess the efficacy and safety of probiotics in managing constipation among the elderly. METHODS: Eight databases were queried for randomized controlled trials (RCTs) investigating probiotics' efficacy in addressing constipation among the elderly until January 2023. The meta-analysis was conducted employing R software version 4.2.2. The Cochrane risk of bias tool was utilized to evaluate the risk of bias, and the GRADE approach was employed to assess the credibility of the evidence concerning the efficacy of probiotics in treating constipation in older individuals. RESULTS: A total of six RCTs involving 444 patients were included. Two studies were rated as low risk of bias. The meta-analysis findings revealed that probiotics, when compared to a placebo, led to an increase in stool frequency (MD = 1.02,95% CI [0.21, 2.07], p<0.05, very low quality), the probiotic group exhibited a notable impact on ameliorating symptoms associated with constipation (OR = 11.28, 95%CI [7.21, 17.64], p < 0.05, very low quality), no significant disparities were observed in terms of efforts to evacuate, manual maneuvers, and the incidence of adverse events (p>0.05). CONCLUSION: The available evidence indicates a degree of uncertainty, ranging from low-to-very low, suggesting the efficacy of probiotics in augmenting bowel frequency and ameliorating constipation-related symptoms among elderly patients with constipation. Nevertheless, given the quality of the studies included, it is advisable to conduct further well-designed investigations with substantial sample sizes to substantiate the findings of this study.

Clinical Trial: Probiotics in Metformin Intolerant Patients with Type 2 Diabetes (ProGasMet).

BACKGROUND: For decades, metformin has been the drug of first choice in the management of type 2 diabetes. However, approximately 2-13% of patients do not tolerate metformin due to gastrointestinal (GI) side effects. Since metformin influences the gut microbiota, we hypothesized that a multi-strain probiotics supplementation would mitigate the gastrointestinal symptoms associated with metformin usage. METHODS AND ANALYSIS: This randomized, double-blind, placebo-controlled, single-center, cross-over trial (ProGasMet study) assessed the efficacy of a multi-strain probiotic in 37 patients with metformin intolerance. Patients were randomly allocated (1:1) to receive probiotic (PRO-PLA) or placebo (PLA-PRO) at baseline and, after 12 weeks (period 1), they crossed-over to the other treatment arm (period 2). The primary outcome was the reduction of GI adverse events of metformin. RESULTS: 37 out of 82 eligible patients were enrolled in the final analysis of whom 35 completed the 32 weeks study period and 2 patients resigned at visit 5. Regardless of the treatment arm allocation, while on probiotic supplementation, there was a significant reduction of incidence (for the probiotic period in PRO-PLA/PLA-PRO: P = 0.017/P = 0.054), quantity and severity of nausea (P = 0.016/P = 0.024), frequency (P = 0.009/P = 0.015) and severity (P = 0.019/P = 0.005) of abdominal bloating/pain as well as significant improvement in self-assessed tolerability of metformin (P < 0.01/P = 0.005). Moreover, there was significant reduction of incidence of diarrhea while on probiotic supplementation in PRO-PLA treatment arm (P = 0.036). CONCLUSION: A multi-strain probiotic diminishes the incidence of gastrointestinal adverse effects in patients with type 2 diabetes and metformin intolerance.

Efficacy and safety of probiotic-supplemented bismuth quadruple therapy for the treatment of Helicobacter pylori infection: a systematic review and meta-analysis.

OBJECTIVE: We performed a meta-analysis to determine whether the addition of probiotics to the bismuth quadruple therapy (BQT) for Helicobacter pylori would improve the incidence of eradication and reduce that of side effects. METHODS: Randomized controlled trials matching the inclusion criteria were collected from PubMed, Embase, Web of Science, and The Cochrane Central Register of Controlled Trials. A Mantel-Haenszel random-effects model was used to calculate pooled risk ratios (RRs) and 95% confidence intervals (CIs) for the incidences of eradication rate, side effects as a whole, diarrhea, and other side effects. RESULTS: Ten studies were selected for inclusion in the meta-analysis. The pooled RRs for the eradication rates in intention-to-treat and per-protocol analyses of the probiotic group vs. the control group were 1.07 (95% CI: 1.02-1.11) and 1.04 (95% CI: 1.00-1.07), respectively. Probiotic supplementation reduced the incidences of side effects (RR 0.58, 95% CI: 0.37-0.91), diarrhea (RR 0.41, 95% CI: 0.25-0.67), and bitter taste (RR 0.63, 95% CI: 0.40-0.99). CONCLUSIONS: The results of this meta-analysis support the use of probiotics in combination with BQT in the clinical management of patients with H. pylori infection.

Efficacy and safety of probiotics and synbiotics for functional constipation in children: A systematic review and meta-analysis of randomized clinical trials.

BACKGROUND & AIM: We aimed to evaluate the efficacy and safety of probiotics and synbiotics in childhood functional constipation. METHODS: PubMed, Embase, Cochrane Library, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP) were searched up to June 2023. Randomized controlled trials involving children diagnosed with FC with Rome III/IV criteria were included. Treatment success, defecation frequency, stool consistency, painful defecation, fecal incontinence, and adverse events were assessed as outcomes. Odds ratios (ORs) and standard mean difference (SMD) with 95% confidence intervals (CIs) were calculated for dichotomous and continuous variables as appropriate. Cochrane risk-of-bias tool version 2 assessed the risk of bias. RESULTS: Seventeen RCTs with 1504 patients were included. Compared to placebo, probiotics significantly improved defecation frequency (SMD 0.40, 95% CI 0.10 to 0.70, I2 = 0%) and fecal incontinence (OR 0.53, 95% CI 0.29 to 0.96, I2 = 0%). However, it did not significantly improve treatment success, painful defecation, and abdominal pain. Probiotics, as add-on therapy, failed to yield a significant difference in treatment success (OR 0.82, 95% CI 0.15 to 4.48, I2 = 52%), defecation frequency (SMD 0.13, 95% CI -0.13 to 0.39, I2 = 0%), defecation consistency (SMD -0.01, 95% CI -0.40 to 0.38, I2 = 1%), fecal incontinence (OR 0.95, 95% CI 0.48 to 1.90, I2 = 0%), and abdominal pain (OR, 0.60, 95% CI 0.24 to 1.53, I2 = 0%) versus laxatives monotherapy. Synbiotics plus laxatives showed no significant effect on defecation frequency (SMD -0.57; 95% CI -1.29 to 0.14, I2 = 74%) and painful defecation (OR, 3.39; 95% CI 0.74 to 15.55, I2 = 0%) versus laxatives alone. CONCLUSIONS: Current evidence did not advocate using probiotics and synbiotics in treating functional constipation in children. At this time, the effects of strain-specific probiotics, probiotics mixtures, and the optimal doses and treatment durations of the probiotics and synbiotics were unclear. Additional rigorous evidence is required to evaluate and establish the effectiveness and safety of probiotics and synbiotics for childhood functional constipation. PROSPERO ID: CRD42020195869.

No effect of multi-strain probiotic supplementation on metabolic and inflammatory markers and newborn body composition in pregnant women with obesity: Results from a randomized, double-blind placebo-controlled study.

BACKGROUND AND AIMS: Modulation of the gut microbiome composition with probiotics may have beneficial metabolic effects in pregnant women with obesity. The aim was to investigate the effect of probiotic supplementation during pregnancy on metabolic and inflammatory markers and the body composition of the offspring. METHODS AND RESULTS: A randomized double-blind trial in 50 pregnant women (pre-pregnancy BMI ≥30 and < 35 kg/m2) comparing multi-strain probiotics (Vivomixx®; 450 billion CFU/d) versus placebo from 14 to 20 weeks of gestation until delivery was carried out. Participants were followed with two predelivery visits at gestational week 27-30 and 36-37 and with one postdelivery visit. All visits included fasting blood samples (C-reactive protein (CRP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), insulin, C-peptide, glucose, glucagon, and glucagon-like peptide-1 (GLP-1)). At delivery, umbilical cord blood samples were collected (GLP-1 and glucagon). At the postdelivery visit, a dual-energy X-ray absorptiometry (DXA) scan of the newborn was performed. Forty-nine of 50 participants completed the study until delivery, and 36 mother-offspring dyads underwent postdelivery examinations including a DXA scan. There were no significant differences in changes in measured biomarkers between the probiotic versus the placebo group. No differences were found in newborn body composition or GLP-1 and glucagon. GLP-1 measured in umbilical blood samples was positively correlated to fat percent in offspring from the probiotic group. CONCLUSION: In this study of pregnant women with obesity and their newborns, there was no effect of probiotic supplementation in mothers or babies on metabolic or inflammatory biomarkers or on body composition of offspring. This study was registered at clinicaltrials.gov as NCT02508844.

A meta-analysis of microbiome therapies for hepatic encephalopathy.

Microbiome therapies may be reported to be effective in hepatic encephalopathy (HE). We thus did a meta-analysis of randomized controlled trials to assess the effect of microbiome therapies for HE. We systematically searched PubMed, Web of Science, EMBASE, and Cochrane Library for randomized controlled trials that compared the different treatments for HE including probiotics, symbiotics, and fecal microbiota transplant (FMT). Meta-analysis was performed to calculate pooled odds ratios (ORs) with corresponding 95% confidence intervals (CIs). Twenty-one studies met our inclusion criteria (N = 1746 participants). Probiotics, synbiotics and FMT significantly reversed minimal HE (MHE) (OR: 0.41, 95% CI: 0.19-0.90, P = 0.03), reduced overt HE (OHE) development (OR, 0.41; 95% CI: 0.28-0.61 P < 0.00001)and the frequency of serious adverse events(SAEs) (OR:0.14, 95% CI: 0.04-0.47, P = 0.001), meanwhile decreased ammonia levels (WMD: -9.26, 95% CI: -16.92 to -1.61; P = 0.02), NCT level (MD = -4.41, 95% CI: -0.87 to -0.22, P = 0.04) and hospitalization rates (OR, 0.38; 95% CI: 0.19-0.79, P = 0.009) compared with placebo/no treatment. Finally, we conclude that microbiome therapies were more effective in improving MHE and preventing progression to OHE, reducing the frequency of SAEs, and decreasing ammonia levels, NCT level, and hospitalization rates when compared to placebo/no treatment.

Probiotic supplementation during antibiotic treatment is unjustified in maintaining the gut microbiome diversity: a systematic review and meta-analysis.

BACKGROUND: Probiotics are often used to prevent antibiotic-induced low-diversity dysbiosis, however their effect is not yet sufficiently summarized in this regard. We aimed to investigate the effects of concurrent probiotic supplementation on gut microbiome composition during antibiotic therapy. METHODS: We performed a systematic review and meta-analysis of randomized controlled trials reporting the differences in gut microbiome diversity between patients on antibiotic therapy with and without concomitant probiotic supplementation. The systematic search was performed in three databases (MEDLINE (via PubMed), Embase, and Cochrane Central Register of Controlled Trials (CENTRAL)) without filters on 15 October 2021. A random-effects model was used to estimate pooled mean differences (MD) with 95% confidence intervals (CI). This review was registered on PROSPERO (CRD42021282983). RESULTS: Of 11,769 identified articles, 15 were eligible in the systematic review and 5 in the meta-analyses. Quantitative data synthesis for Shannon (MD = 0.23, 95% CI: [(-)0.06-0.51]), Chao1 (MD = 11.59 [(-)18.42-41.60]) and observed OTUs (operational taxonomic unit) (MD = 17.15 [(-)9.43-43.73]) diversity indices revealed no significant difference between probiotic supplemented and control groups. Lacking data prevented meta-analyzing other diversity indices; however, most of the included studies reported no difference in the other reported α- and ß-diversity indices between the groups. Changes in the taxonomic composition varied across the eligible studies but tended to be similar in both groups. However, they showed a potential tendency to restore baseline levels in both groups after 3-8 weeks. This is the first meta-analysis and the most comprehensive review of the topic to date using high quality methods. The limited number of studies and low sample sizes are the main limitations of our study. Moreover, there was high variability across the studies regarding the indication of antibiotic therapy and the type, dose, and duration of antimicrobials and probiotics. CONCLUSIONS: Our results showed that probiotic supplementation during antibiotic therapy was not found to be influential on gut microbiome diversity indices. Defining appropriate microbiome diversity indices, their standard ranges, and their clinical relevance would be crucial.

Microbiome-targeting therapies in the neonatal intensive care unit: safety and efficacy.

Microbiome-targeting therapies have received great attention as approaches to prevent disease in infants born preterm, but their safety and efficacy remain uncertain. Here we summarize the existing literature, focusing on recent meta-analyses and systematic reviews that evaluate the performance of probiotics, prebiotics, and/or synbiotics in clinical trials and studies, emphasizing interventions for which the primary or secondary outcomes were prevention of necrotizing enterocolitis, late-onset sepsis, feeding intolerance, and/or reduction in hospitalization length or all-cause mortality. Current evidence suggests that probiotics and prebiotics are largely safe but conclusions regarding their effectiveness in the neonatal intensive care unit have been mixed. To address this ambiguity, we evaluated publications that collectively support benefits of probiotics with moderate to high certainty evidence in a recent comprehensive network meta-analysis, highlighting limitations in these trials that make it difficult to support with confidence the routine, universal administration of probiotics to preterm infants.

Effect and safety of probiotics for treating urticaria: A systematic review and meta-analysis.

BACKGROUND: To assess the effect and safety of probiotics for treating urticaria. METHODS: Randomized controlled trial (RCT) papers on the probiotics treatment published before May 2019 were retrieved from various databases like PubMed, EMbase, MEDLINE (Ovid), SCI-Hub, Springer, ClinicalKey, VIP, and CNKI. The treatment plan that we include are oral administration of single probiotic, multiple probiotics, and the combination of probiotics and antihistamines. Meta-analysis of the data was performed by RevMan 5.3 software. RESULTS: A total of nine RCT papers were included: four papers for oral administration of single probiotic, three papers for oral administration of multiple probiotics, and two papers for oral administration of a probiotic combined with antihistamines. The results of meta-analysis showed that the therapeutic effect of the probiotic group was significantly higher than the control group (placebo or antihistamines) (RR = 1.09, 95% CI: 1.03-1.16, p = 0.006). And compared with the placebo group, the therapeutic effect of single probiotic group was significantly improved (RR = 1.11, 95% CI: 1.01-1.21, p = 0.03). Regarding therapeutic effect, there was no statistically significant difference between the multiple probiotics group and placebo group (RR = 1.00, 95% CI: 0.94 ~ 1.07, p = 0.91); the therapeutic effect of single probiotic combined antihistamine group was significantly higher than the antihistamine group (RR = 1.13, 95% CI: 1.07-1.19, p < 0.0001). Regarding the incidence of adverse reactions, there was no significant difference between the probiotic group and the control group (p = 0.46). CONCLUSION: The treatment plan of oral administration of probiotics has significant therapeutic effects on urticaria, but the therapeutic effects of the administration of multiple probiotics and the safety of probiotic therapy are still not yet obvious. Some large-scale, multi-centered RCT studies are needed in the future for clarification.

Maternal and infant microbiome: next-generation indicators and targets for intergenerational health and nutrition care.

Microbes are commonly sensitive to shifts in the physiological and pathological state of their hosts, including mothers and babies. From this perspective, the microbiome may be a good indicator for diseases during pregnancy and has the potential to be used for perinatal health monitoring. This is embodied in the application of microbiome from multi body sites for auxiliary diagnosis, early prediction, prolonged monitoring, and retrospective diagnosis of pregnancy and infant complications, as well as nutrition management and health products developments of mothers and babies. Here we summarized the progress in these areas and explained that the microbiome of different body sites is sensitive to different diseases and their microbial biomarkers may overlap between each other, thus we need to make a diagnosis prudently for those diseases. Based on the microbiome variances and additional anthropometric and physical data, individualized responses of mothers and neonates to meals and probiotics/prebiotics were predictable, which is of importance for precise nutrition and probiotics/prebiotics managements and developments. Although a great deal of encouraging performance was manifested in previous studies, the efficacy could be further improved by combining multi-aspect data such as multi-omics and time series analysis in the future. This review reconceptualizes maternal and infant health from a microbiome perspective, and the knowledge in it may inspire the development of new options for the prevention and treatment of adverse pregnancy outcomes and bring a leap forward in perinatal health care.

Efficacy and safety of probiotics in the treatment of irritable bowel syndrome: A systematic review and meta-analysis of randomised clinical trials using ROME IV criteria.

BACKGROUND: Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disorder which affects a great number of patients globally. Clinical trials and meta-analyses have evaluated different therapies for IBS. Some of them have shown that probiotics play a significant role in the management of IBS-patients. Nevertheless, results are controversial, and the efficacy of the administration of probiotics remains to be confirmed, especially in regard to which type of probiotic-strains are beneficial. AIM: The aim of the present meta-analysis is to assess the efficacy and safety of the administration of probiotics to IBS-patients with a diagnosis based on Rome IV criteria, which is performed for the first time. METHODS: Electronic databases (Pubmed, Scopus and Cochrane) were searched until 26.01.2023 for randomized controlled trials (RCTs) studying the administration of probiotics in adult IBS-patients, who were categorized according to the Rome IV criteria. The risk of bias was assessed using the Cochrane Risk of Bias tool (ROB) 2.0. Weighted and standardized mean difference with the 95% confidence intervals were used for the synthesis of the results. Primary outcomes were the decrease of IBS-Symptom Severity Score (IBS-SSS) and decrease of abdominal pain. The secondary outcomes were the improvement in quality of life (QoL) and the decrease of bloating. Lastly, the adverse effects of probiotics were evaluated. The protocol of the study has been registered at protocols.io (DOI dx.doi.org/10.17504/protocols.io.14egn218yg5d/v1). RESULTS: Six double-blind (N = 970) placebo-control RCTs fulfilled the inclusion criteria and overall, nine different strains of probiotics were examined. No significant reduction in IBS-SSS (WMD -43.2, 95% CI -87.5 to 1.0, I2 = 82.9%) was demonstrated, whereas a significant decrease regarding abdominal pain (SMD -0.94, 95% CI -1.53 to -0.35, I2 = 92,2) was shown. Furthermore, no correlation between improvement of QoL and the use of probiotics (SMD -0.64, 95% CI -1.27 to 0.00, I2 = 93,9%) was shown. However, probiotics were associated with a significant reduction in bloating (SMD -0.28, 95% CI -0.47 to -0.09, I2 = 36,0%). A qualitative synthesis was conducted about adverse events and showed that the use of probiotics' is safe without severe adverse events. CONCLUSIONS: The administration of probiotics to IBS-patients demonstrated a positive effect on pain and bloating, but due to significant heterogeneity and confounding factors, that were not examined in the included studies, a definitive statement cannot be made. Moreover, probiotics did not lead to an improvement in other parameters. There is a need for larger RCTs in IBS-patients diagnosed according to Rome IV (not III) criteria and especially it is essential to be conducted RCTs which examine the administration of specific strains and have similar methodological characteristics.