Candida endophthalmitis and Candida pneumonia after trans-urethral lithotripsy: A case report.

Key Clinical Message: Invasive candidiasis may be one of the serious complications of transurethral lithotripsy. Candiduria before this procedure should be assessed, and antifungals should be prescribed. Abstract: This case is about a 44-year-old diabetic female patient who, after trans-urethral lithotripsy with double-J stent insertion, was diagnosed with Candida pneumonia and Candida endophthalmitis.

Sequential therapy versus quadruple therapy for Helicobacter pylori eradication: A prospective double-blinded randomized controlled trial.

Backgrounds and Aims: This controlled randomized clinical trial was designed to compare effectiveness, side effects, and severity of symptoms before and after therapy between quadruple (QT) and sequential regimens (SQ) for Helicobacter Pylori (H. pylori). Methods: Patients were randomly allocated into two groups. Group A received a 14-day QT including pantoprazole 40 mg q12 h, bismuth subcitrate 240 mg q12 h, clarithromycin 500 mg q12 h, and amoxicillin 1000 mg q12 h and group B received ST including pantoprazole 40 mg q12 h and amoxicillin 1000 mg q12 h for the initial 5 days followed by pantoprazole 40 mg q12 h, clarithromycin 500 mg q12 h and tinidazole 500 mg q12 h for the next 5 days. Adverse drug reactions and patients' compliance were assessed after finishing the treatment course and also 4 weeks after. All patients were naive, therefore ST and QT were first-line therapies. To evaluate severity of symptoms we used Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) before taking the first dose of regimens, at the end of therapy, and also 4 weeks after (follow-up). Results: The mean age in Group A (n = 83) was 48.55 ± 12.56 and 47.24 ± 12.78 in Group B (n = 79). No statistically significant differences were observed between the two groups regarding age, gender, endoscopic findings, and also eradication rate. The analysis demonstrated a significant decrease in SF-LDQ score between baseline and after therapy and baseline and follow-up in both regimen groups. Both regimens were well tolerated by the majority of patients, and there were no significant differences between the two groups in terms of adverse drug reactions. Conclusion: This study showed that ST can be used as an alternative first-line therapy to QT in patients with H. pylori infection.

The influence of propolis plus Hyoscyamus niger L. against COVID-19: A phase II, multicenter, placebo-controlled, randomized trial.

The incubation period of COVID-19 symptoms, along with the proliferation and high transmission rate of the SARS-CoV-2 virus, is the cause of an uncontrolled epidemic worldwide. Vaccination is the front line of prevention, and antiinflammatory and antiviral drugs are the treatment of this disease. In addition, some herbal therapy approaches can be a good way to deal with this disease. The aim of this study was to evaluate the effect of propolis syrup with Hyoscyamus niger L. extract in hospitalized patients with COVID-19 with acute disease conditions in a double-blinded approach. The study was performed on 140 patients with COVID-19 in a double-blind, randomized, and multicentral approach. The main inclusion criterion was the presence of a severe type of COVID-19 disease. The duration of treatment with syrup was 6 days and 30 CC per day in the form of three meals. On Days 0, 2, 4, and 6, arterial blood oxygen levels, C-reactive protein (CRP), erythrocyte sedimentation rate, and white blood cell, as well as the patient's clinical symptoms such as fever and chills, cough and shortness of breath, chest pain, and other symptoms, were recorded and analyzed. Propolis syrup with H. niger L. significantly reduces cough from the second day, relieving shortness of breath on the fourth day, and significantly reduces CRP, weakness, and lethargy, as well as significantly increased arterial blood oxygen pressure on the sixth day compared to the placebo group (p < 0.05). The results in patients are such that in the most severe conditions of the disease 80% < SpO2 (oxygen saturation), the healing process of the syrup on reducing CRP and increasing arterial blood oxygen pressure from the fourth day is significantly different compared with the placebo group (p < 0.05). The use of syrup is associated with a reduction of 3.6 days in the hospitalization period compared with the placebo group. Propolis syrup with H. niger L. has effectiveness in the viral and inflammatory phases on clinical symptoms and blood parameters and arterial blood oxygen levels of patients with COVID-19. Also, it reduces referrals to the intensive care unit and mortality in hospitalized patients with COVID-19. So, this syrup promises to be an effective treatment in the great challenge of COVID-19.

Epstein-Barr virus infection leading to multiorgan involvement in an immunocompetent man.

Epstein-Barr virus (EBV) is a commonly asymptomatic widespread human herpes virus affecting over 90% of the population. It mostly originates complications like simple sore throat and infectious mononucleosis but severe manifestations are rare. Herein we report a 30-year-old immunocompetent man who presented with fever, sore throat, general weakness, and drowsiness. The diagnosis was formulated based on the positive RT-PCR test for EBV DNA and serological detection of IgM antibody against viral capsid antigen. The patient developed severe meningoencephalitis, myocarditis, and bowel perforation and passed away after 72 days of hospitalization.

Efficacy and safety of an inactivated virus-particle vaccine for SARS-CoV-2, BIV1-CovIran: randomised, placebo controlled, double blind, multicentre, phase 3 clinical trial.

OBJECTIVE: To report the efficacy, safety, and exploratory immunogenicity findings of two 5 µg doses of the BIV1-CovIran vaccine. DESIGN: Randomised, placebo controlled, double blind, multicentre, phase 3 clinical trial. SETTING: In six cities of Iran, including Bushehr, Isfahan, Karaj, Mashhad, Shiraz, and Tehran. The first vaccine or placebo injection of the first participant was on 16 May 2021 in Tehran. The last vaccine or placebo injection of the last participant occurred on 15 July 2021 in Isfahan. PARTICIPANTS: 20 000 participants aged 18-75 years were randomly assigned to the intervention or placebo groups with a ratio of 2:1. INTERVENTION: 5 µg vaccine or placebo with the interval of 28 days. MAIN OUTCOME MEASURES: Vaccine efficacy for a 90 day follow-up period, safety and explanatory immunogenicity assessment, and variant detection during the trial. RESULTS: 20 000 participants were recruited and randomly assigned to receive BIV1-CovIran (n=13 335 (66.7%)) or placebo (n=6665 (33.3%)). Participants' mean age was 38.3 (standard deviation 11.2) years, and 6913 (34.6%) were female. Among vaccinated participants that had covid-19 reported during the follow-up (median 83 days), 758 (5.9%) had symptoms, 144 (1.1%) had severe infection, and seven (0.1%) were critical. Among participants who received placebo during the follow-up, 688 (10.7%) had symptoms, 221 (3.4%) had severe infection, and 19 (0.3%) were critical. Overall efficacy was 50.2% (95% confidence interval 44.7% to 55.0%) against symptomatic covid-19, 70.5% (63.7% to 76.1%) against severe disease, and 83.1% (61.2% to 93.5%) against critical cases. Two deaths were reported in the efficacy population in the placebo group, no deaths were from the intervention group. During follow-up, 41 922 adverse events were reported: 28 782 (68.7%) were adverse reactions, of which 19 363 (67.3%) were in the intervention group. Most adverse reactions were mild or moderate in severity (grade 1 or 2) and self-limiting. No serious adverse events were related to the injections. For variant investigation, of 119 participants positive for the SARS-CoV-2 variant, 106 (89.1%) were positive for the delta variant. CONCLUSIONS: A two dose regimen of the BIV1-CovIran vaccine conferred efficacy of 50.2% against symptomatic covid-19, 70.5% against severe disease, and 83.1% against critical disease. Vaccination was well tolerated, with no safety concerns raised. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT20201202049567N3. FUNDING: Shifa-Pharmed Industrial Group.

Evaluation of Maternal and Fetal Outcomes in Pregnant Women with COVID-19 based on Different Trimesters.

Background: COVID-19 is the leading cause of the recent pandemic in the globe. This disease might have different effects on the maternal and fetal outcomes in pregnancy. The aim of this study was to assess these outcomes in pregnant women with COVID-19 infections in different trimesters. Materials and Methods: This is a prospective cohort study that was performed in February 2020 to August 2021 in Isfahan on 430 pregnant women with definite diagnosis of COVID-19 infection admitted to our medical centers. The included cases were followed based on the gestational age in which they were diagnosed with COVID-19 infection. Patients were divided into three groups (first, second, and third trimesters) based on COVID-19 infection. Results: The frequency of requiring mechanical ventilation was higher in mothers with COVID-19 in the second trimester (P = 0.049) and the frequency of PIH was significantly higher in mothers with COVID-19 in the third trimester compared to other women (P = 0.009). Fetal growth restriction (FGR) was also observed in 22 patients (5.3%) that was mostly observed with COVID-19 in the third trimester (P = 0.012). Oligohydramnios and fetal distress leading to C/S were observed in 19 patients (4.6%) and 12 patients (2.9%), respectively. The majority of maternal mortality was among cases with COVID-19 infection in the third trimester (44.4%). Conclusion: We observed higher maternal and fetal complications in women especially those in the third trimester. Our results were in line with the findings of previous studies. Women with COVID-19 infection in the third trimester had highest frequencies of preterm labor and FGR.

The Effectiveness of Silymarin in the Prevention of Anti-tuberculosis Drug-induced Hepatotoxicity: A Randomized Controlled Clinical Trial.

Background: Several animal studies have shown the protective effect of silymarin (the extract of Silybum marianum seeds) against anti-tuberculosis drug-induced hepatotoxicity (ATDH). However, the knowledge of ATDH of silymarin in humans is scarce. In this study, we aimed to clinically evaluate it. Methods: During this randomized controlled clinical trial, 36 new cases of tuberculosis (TB) were enrolled to receive either silymarin 150 mg twice daily for two weeks along with a standard anti-TB therapeutic regimen (experimental group; n = 16) or standard anti-TB therapeutic regimen alone (control group; n = 21). Liver function tests (serum AST, ALT, ALP, and total bilirubin) at the end of weeks 1 and 2 as well as the rate of ATDH during the study were determined and compared between the groups. Results: No significant differences between the experimental and control groups were observed at the end of the first week regarding liver function tests; However, at the end of the second week, the mean serum levels of AST (P = 0.03) and ALP (P = 0.04) were significantly lower in the experimental group. ALT (P = 0.016) and ALP (P = 0.027) levels in the experimental group significantly decreased during the study, while the changes in the control group were not significant. Two patients in the control group (9.5%) developed ATDH, while no one in the experimental group manifested this adverse effect. Conclusions: Our study suggests that silymarin use has the potential for the reduction of anti-TB drug-induced hepatotoxicity.

Efficacy of plasmapheresis in neutropenic patients suffering from cytokine storm because of severe COVID-19 infection.

Background: With the emergence of the coronavirus disease 2019 (COVID-19) and inability of healthcare systems to control the disease, various therapeutic theories with controversial responses have been proposed. Plasmapheresis was administered as a medication. However, the knowledge of its efficacy and indications is inadequate. This study evaluated the use of plasmapheresis in critically ill patients with cancer. Methods: This randomized clinical trial was conducted on 86 patients with malignancies, including a control group (N=41) and an intervention group (N=45) with severe COVID-19 during 2020-21. Both groups were treated with routine medications for COVID-19 management according to national guidelines, and plasmapheresis was applied to the intervention group. C-reactive protein (CRP), D-dimer, ferritin, lactate dehydrogenase, hemoglobin, and white blood cell, polymorphonuclear, lymphocyte, and platelet levels were measured at admission and at the end of plasmapheresis. Other variables included neutrophil recovery, intensive care unit admission, intubation requirements, length of hospital stay, and hospitalization outcomes. Results: CRP(P<0.001), D-dimer (P<0.001), ferritin (P=0.039), and hemoglobin (P=0.006) levels were significantly different between the groups after the intervention. Neutrophil recovery was remarkably higher in the case than in the control group (P<0.001). However, plasmapheresis did not affect the length of hospital stay (P=0.076), which could have significantly increased survival rates (P<0.001). Conclusion: Based on the study findings, plasmapheresis led to a significant improvement in laboratory markers and survival rate in patients with severe COVID-19. These findings reinforce the value of plasmapheresis in cancer patients as a critical population suffering from neutropenia and insufficient immune responses.

Comparing inhaled colistin with inhaled fosfomycin/tobramycin as an adjunctive treatment for ventilator-associated pneumonia: An open-label randomized controlled trial.

PURPOSE: Although investigations are limited, adjunctive aerosolized antibiotics have been advised in the setting of gram-negative ventilator-associated pneumonia (VAP). This study aimed to compare the efficiency of inhaled colistin with inhaled fosfomycin/tobramycin in treating VAP due to extensively drug-resistant (XDR) Acinetobacter baumannii. METHODS: This single center open-label randomized controlled trial included 60 patients who developed XDR A. bumannii VAP. Eligible participants were randomly assigned to two groups (no. 30). Regardless of the assignment, all participants received meropenem (2 g as a 3-h extended infusion every 8 h) plus intravenous colistin (a loading dose of 9 million IU and then 4.5 million IU every 12 h). The control group was given inhaled colistin (1 million IU every 8 h), and the case group received inhaled tobramycin/fosfomycin (300 mg every 12 h/80 mg every 12 h) as adjunctive therapy. The primary outcome was treatment duration, and the secondary outcomes were Clinical Pulmonary Infection Score (CPIS) trend and mortality rate in the groups. The decision to stop treatment was made by the treating physician. RESULTS: The mean treatment duration was 13.73 ± 3.22 days in the colistin group and 10.85 ± 2.84 days in the tobramycin/fosfomycin group; the mean treatment duration in the latter group was lower significantly (P = 0.001). CPIS was decreased in the groups significantly (P < 0.001), but the mean changes of CPIS were significantly different between the groups, and in the inhaled tobramycin/fosfomycin group, a greater reduction (P = 0.005) was observed. Two (6.67%) patients in the control group and three (10%) patients in the case group died. CONCLUSION: The use of inhaled tobramycin/fosfomycin in cases with XDR A. bumannii VAP was associated with a shorter treatment duration in this open-label trial.

Evaluation of Synbiotics in the Prevention of Ventilator-Associated Pneumonia: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial.

Background: Ventilator-associated pneumonia (VAP) is one of the most common nosocomial infections. The role of probiotics in preventing VAP is still questionable. This study aimed at evaluating the effect of synbiotic FamiLact 2plus on the prevention of VAP in patients admitted to the intensive care unit (ICU). Methods: A total of 80 mechanically ventilated patients were included and divided into two groups of 40. Group 1 received FamiLact 2plus, and group 2 received placebo. The outcome variables were compared, including the incidence of VAP, the time interval between the onset of ventilation and VAP, the duration of mechanical ventilation, and the length of stay in the ICU. Results: VAP is documented in four patients (10%) in group 1 and 11 patients (27.5%) in group 2 (P = 0.045). The length of stay in the ICU in group 1 was significantly shorter than in group 2, and the time interval between the start of intubation and the onset of VAP in group 1 was longer than in the placebo group. During the intervention, 15 patients in group 1 (37.5%) and 26 patients in group 2 (65%) developed diarrhea, which was a significant difference (P = 0.02). Conclusions: Synbiotic is associated with a reduction in the incidence of VAP as well as a reduction in ICU stay and delayed VAP.

The Effect of Vitamin B6 in the Prevention of Hematological Adverse Effects of Linezolid in Patients with Chronic Osteomyelitis: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

Background: Due to the contradictory results of the effects of Vitamin B6 in reducing the hematotoxic effects of linezolid, the present study aimed to investigate the possible role of Vitamin B6 administration in reducing linezolid-related hematological toxicities in patients with chronic osteomyelitis. Materials and Methods: In a randomized double-blind placebo-controlled clinical trial, patients with chronic osteomyelitis were randomly divided into two groups (n = 40 each): the intervention group received Vitamin B640 mg twice daily from the beginning of treatment with linezolid and the control group received placebo with linezolid, both for 21 days. Blood variables including hemoglobin (Hb), white blood cells (WBC), and platelets (PLT) were measured at baseline and at the end of the 1st, 2nd, and 3rd weeks (days 7, 14, and 21) of the intervention. Results: There was no significant difference between the groups regarding the count of WBC and PLT and level of Hb at evaluated time points. Furthermore, there was a significant decreasing trend in all parameters within both groups; however, the decreasing trend of both PLT and WBC was slower in the intervention (Vitamin B6) group compared to the placebo group. Conclusion: Vitamin B6 has no significant effect in the reduction of hematological adverse effects of linezolid in chronic osteomyelitis patients. However, it could retard the decreasing trend of WBC and PLT counts.

Diagnostic Value of Natural Killer Cells, CD56+ CD16+ Natural Killer Cells, NLRP3, and Lactate Dehydrogenase in Severe/Critical COVID-19: A Prospective Longitudinal Study According to the Severe/Critical COVID-19 Definitions.

Innate immunity, as the first line of defense of our immune system, plays a crucial role in defending against SARS-CoV-2 infection and also its immunopathogenesis. We aim to investigate the immune status of natural killer (NK) cells, natural killer T (NKT) cells, and NLRP3 gene expression in COVID-19 patient blood samples. The immunophenotype of NK cell subsets and NKT cells was detected by flow cytometry and the expression of NLRP3 gene assessed by reverse transcriptase real-time polymerase chain reaction in 44 COVID-19 patients and 20 healthy individuals. The percentage of most of NK cell subpopulation and NKT cells was significantly decreased in COVID-19 patients. The percentage of CD56dim CD16- NK cell subsets, and NLRP3 gene expression increased. The percentage of total NK cells, CD56+ CD16+ NK cells, and NLRP3 gene expression had acceptable sensitivity and specificity for assisting diagnosis of severe/critical COVID-19. O2 saturation% and lactate dehydrogenase levels showed valuable diagnostic value to identify critical cases. The declined NK and NKT cells in COVID-19 patients and enhanced NLRP3 gene expression were associated with disease severity. Total NK cells, CD56+ CD16+ NK cells, and NLRP3 gene expression might be used as meaningful indicators for assisting diagnosis of severe/critical COVID-19.

Antibiotic use during the first 6 months of COVID-19 pandemic in Iran: A large-scale multi-centre study.

WHAT IS KNOWN AND OBJECTIVE: Although antibiotics are ineffective against viral infections, epidemiological studies have revealed that the COVID-19 pandemic resulted in the overuse of antibiotics and disruption of antimicrobial stewardship programmes. We investigated the pattern of antibiotic use during the first 6 months of the COVID-19 pandemic in Iran. METHODS: A multi-centre retrospective study was designed to investigate the use of 16 broad-spectrum antibiotics in 12 medical centres. The rate of antibiotic use was calculated and reported based on the Defined Daily Dose (DDD) per 100 hospital bed-days. The bacterial co-infection rate was also reported. RESULTS AND DISCUSSION: Totally, 43,791 hospitalized COVID-19 patients were recruited in this study. It was found that 121.6 DDD of antibiotics were used per 100 hospital bed-days, which estimated that each patient received approximately 1.21 DDDs of antibiotics every day. However, the bacterial co-infections were detected only in 14.4% of the cases. A direct correlation was observed between the rate of antibiotic use and mortality (r[142] = 0.237, p = 0.004). The rate of antibiotic consumption was not significantly different between the ICU and non-ICU settings (p = 0.15). WHAT IS NEW AND CONCLUSION: In this study, widespread antibiotic use was detected in the absence of the confirmed bacterial coinfection in COVID-19 patients. This over-consumption of broad-spectrum antibiotics may be associated with increased mortality in hospitalized COVID-19 patients, which can be an alarming finding.

COVID-19-associated mucormycosis: A review of an emergent epidemic fungal infection in the era of COVID-19 pandemic.

At a time when the COVID-19's second wave is still picking up in countries like India, a number of reports describe the potential association with a rise in the number of cases of mucormycosis, commonly known as the black fungus. This fungal infection has been around for centuries and affects those people whose immunity has been compromised due to severe health conditions. In this article, we provide a detailed overview of mucormycosis and discuss how COVID-19 could have caused a sudden spike in an otherwise rare disease in countries like India. The article discusses the various symptoms of the disease, class of people most vulnerable to this infection, preventive measures to avoid the disease, and various treatments that exist in clinical practice and research to manage the disease.

The effectiveness of gabapentin and gabapentin/montelukast combination compared with dextromethorphan in the improvement of COVID-19- related cough: A randomized, controlled clinical trial.

INTRODUCTION: Cough is one of the most common presenting symptoms of COVID-19, which can persist for weeks or months. OBJECTIVE: The goal of this study was to evaluate the effectiveness of gabapentin (GBT) alone and in combination with montelukast (MTL) for improving cough. METHODS: In this open-label randomized controlled clinical trial, eligible cases were patients hospitalized with moderate to severe COVID-19 who had cough with a Breathlessness, Cough, and Sputum Scale (BCSS) score of at least 2 based on its cough subscale. The participants were randomly assigned to three groups including two experimental groups and one control group. The first and second experimental groups received GBT and GBT/MTL, respectively, whereas the control group received dextromethorphan (DXM). Treatment duration was 5 days in all groups. Before and after the interventions, the severity of cough was evaluated using BCSS scale and Visual Analog Scale (VAS). RESULTS: A total of 180 patients were included; GPT, GPT/MTL, and DXM consisted of 76, 51, and 53 patients, respectively. There was no significant difference between the three groups in terms of age, gender, and comorbidities (P > 0.05). Regarding BCSS and VAS scores, there was significant reduction from the baseline values in all groups (P < 0.0001), with the change rate being significantly higher in DXM group. The amount of reduction of BCSS in the GPT/MTL group was significantly more than the GPT group, whereas there was no significant difference between the two groups regarding VAS score. Although the duration of hospitalization differed between the groups with the GPT/MTL group having the shortest duration, the difference was statistically significant only between the GPT and GPT/MTL groups (P < 0.0001). CONCLUSION: GPT, both alone and in combination with MTL, improves cough frequency and severity in hospitalized patients with COVID-19, with the combination being more efficacious. This regimen may be useful in patients who cannot tolerate opioids.

The efficacy of curcumin-piperine co-supplementation on clinical symptoms, duration, severity, and inflammatory factors in COVID-19 outpatients: a randomized double-blind, placebo-controlled trial.

BACKGROUND: COVID-19 pandemic has made the disease a major global problem by creating a significant burden on health, economic, and social status. To date, there are no effective and approved medications for this disease. Curcumin as an anti-inflammatory agent can have a positive effect on the control of COVID-19 complications. This study aimed to assess the efficacy of curcumin-piperine supplementation on clinical symptoms, duration, severity, and inflammatory factors in patients with COVID-19. METHODS: Forty-six outpatients with COVID-19 disease were randomly allocated to receive two capsules of curcumin-piperine; each capsule contained 500 mg curcumin plus 5 mg piperine or placebo for 14 days. RESULTS: Mean changes in complete blood count, liver enzymes, blood glucose levels, lipid parameters, kidney function, and c-reactive protein (CRP) were not significantly different between the two groups. There was a significant improvement in health status, including dry cough, sputum cough, ague, sore throat, weakness, muscular pain, headache, and dyspnea at week 2 in both curcumin-piperine and placebo groups (P value < 0.05); however, the improvement in weakness was more in the curcumin-piperine group than with placebo group (P value 025). CONCLUSION: The present study results showed that curcumin-piperine co-supplementation in outpatients with COVID-19 could significantly reduce weakness. However, in this study, curcumin-piperine co-supplementation could not significantly affect the other indices, including biochemical and clinical indices. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20121216011763N46 . 2020-10-31.

The Effect of Topical Cow's Milk on the Healing of Diabetic Foot Ulcers: A Randomized Controlled Pilot Clinical Trial.

Diabetic foot ulcer (DFU) is a very serious side effect among the diabetic patients with substantial clinical and economic consequences. The aim of this study was to investigate the efficacy of cows' milk topical ointment, as an available and cost-effective natural product, on accelerating the healing of DFU. In this randomized controlled clinical trial, patients with grade 1 or 2 DFU were randomly divided into two groups of intervention (n = 50) and control (n = 49). For patients of intervention group, cows' milk 20% topical ointment was applied on the ulcer once daily for two weeks, while a type of novel dressing was used for control group with the same frequency and duration. Both groups received usual standard wound care measures. The percentage of change in the ulcer size and the number of cases with complete wound healing (>90% reduction in the ulcer size) were recorded in the both groups. The ulcer size significantly reduced in both groups on the seventh and 14th days of intervention; however, the percentage of reduction was significantly higher in the intervention (milk) group compared to control at both time points (44.64 ± 15.98 vs. 24.95 ± 12.78, P < .001; 67.67 ± 22.15 vs. 42.87 ± 19.74, P < .001). Furthermore, although more patients in the intervention group (n = 4, 8%) showed complete healing of the ulcer compared to control (n = 0), the difference was not statistically significant (P = .117). Cow's milk 20% topical ointment improves and accelerates the healing of diabetic foot ulcers. However, more clinical studies are required to confirm these effects.

The Effect of Plantago major Hydroalcoholic Extract on the Healing of Diabetic Foot and Pressure Ulcers: A Randomized Open-Label Controlled Clinical Trial.

Aims: Diabetic foot ulcer (DFU) and pressure ulcer (PU) both are common types of ulcers worldwide. The wound healing effect of Plantago major leaves has been shown in a few animal studies. This study aimed to evaluate the clinical efficacy of P. major hydroalcoholic extract on DFU and PU healing. Methods: In this clinical trial, patients with DFU or PU who met the inclusion criteria were randomly assigned to drug (P. major) or control groups. For patients in the drug group, Plantago extract 10% topical gel was applied on the wound once daily concurrent with dressing and routine wound care for two weeks, while for the control group, an appropriate novel dressing was used along with routine wound care for the same duration. The percentage of wound size reduction at the end of the seventh and 14th days of intervention was recorded and compared between the groups. Results: Fifty and 44 patients in drug and control groups, respectively, completed the interventions. Plantago extract gel significantly resulted in more reduction in the wound size compared to control at the end of the first (64.90 ± 29.75% vs. 33.11 ± 26.55%; P < 0.001) and second week (86.85 ± 24.34% vs. 52.87 ± 32.41%; P < 0.001). Furthermore, the number of patients with complete wound healing in the drug group (n = 32, 64%) was significantly more than the control group (n = 9, 20.45%; OR: 3.129, 95% CI: 1.685-5.809, P < 0.001). Conclusion: The use of 10% topical gel of P. major leaf extract results in the acceleration of DFU and PU healing. Key points: Application of P. major topical gel results in the acceleration of diabetic foot ulcer and pressure ulcer healing. - P. major extract helps reducing the wound's erythema.- P. major leaf extract assists decreasing the wound size.- The number of patients completing wound healing process is higher among whom undergoing P. major dressing.

Gut microbiota in burned patients with Clostridioides difficile infection.

BACKGROUND: The survival rate of patients with severe burn is positively associated with increasing the incidence of the Clostridioides difficile (C. difficile) infection (CDI). The surviving rate of severe burn patients now has an improved but the incidence of Clostridioides difficile (C. difficile) infection (CDI) has been continues increasing during recent two decades. This study assessed the molecular typing and phenotypic characterization isolates of C. difficile in burn patients with diarrhea, as well as environmental and skin infections with C. difficile spores at a referral burn hospital in Isfahan, Iran. It mainly aimed to evaluate the dominant bacterial structure in the gut microbiome of burned subjects with and without CDI. METHODS: In general, 309 samples were collected from 189 burned patients with hospital-acquired diarrhea and 120 swabs were collected from the healthcare workers' dominant hands, different sites of patients' skin, and medical tools. In addition, C. difficile isolates were characterized considering the existence of antibiotic resistance and toxin genes. Clinical cultures with identification of organisms and antibiotic susceptibility were done. C. difficle isolates were then genotyped and compared to clinical outcomes. Finally, the clinical characteristics of the participants were gathered through their records, and the bacterial targets of the gut microbiome were detected using quantitative real-time polymerase chain reaction (PCR). RESULTS: Based on the findings, 51 C. difficile isolates were detected from 189 severe burn patients hospitalized in the hospital. Further, PCR amplification tcdB and tcdA showed 23 isolates (12.2%) as toxigenic. Overall, 18.3% (22/120) of skin and environment samples demonstrated a positive result for C. difficile colonization. A low concentration of metronidazole and vancomycin (MIC90, 0.5, and 1.2 mg/L) inhibited all toxigenic C. difficile strains. Moreover, these isolates represented the highest rates of resistance to moxifloxacin and clindamycin (MIC90, 0.5, and 1.6 mg/L). A significantly reduced abundance of Clostridium spp., Bacteroidetes, and Bifidobacterium and an increase in the quantity of Firmicutes was observed in the gastrointestinal microbiome of burn patients (P < 0.01). Burn patients with CDI showed a significant decrease in Faecalibacterium prausnitzii (F. prausnitzii) while higher Akkermansia muciniphila (A. muciniphila) loads in comparison with healthy controls (P < 0.001 and P < 0.05). Contrarily, burned cases displayed increased levels of opportunistic pathogenic bacteria including the members of Enterococcus spp. and Escherichia coli (P < 0.05). CONCLUSIONS: Despite appropriate infection control strategies in the burn intensive care unit, CDI remains prevalent in severe burn patients. Eventually, the overgrowth of A. muciniphila and the decreased abundance of F. prausnitzii in burn cases with CDI could be potential predictive microbiome biomarkers in burned patients.