ABSTRACT
Probiotics have been used for decades to alleviate the negative side-effects of oral antibiotics, but our mechanistic understanding on how they work is so far incomplete. Here, we performed a metagenomic analysis of the fecal microbiota in participants who underwent a 14-d Helicobacter pylori eradication therapy with or without consumption of a multi-strain probiotic intervention (L. paracasei CNCM I-1518, L. paracasei CNCM I-3689, L. rhamnosus CNCM I-3690, and four yogurt strains) in a randomized, double-blinded, controlled clinical trial. Using a strain-level analysis for detection and metagenomic determination of replication rate, ingested strains were detected and replicated transiently in fecal samples and in the gut during and following antibiotic administration. Consumption of the fermented milk product led to a significant, although modest, improvement in the recovery of microbiota composition. Stratification of participants into two groups based on the degree to which their microbiome recovered showed i) a higher fecal abundance of the probiotic L. paracasei and L. rhamnosus strains and ii) an elevated replication rate of one strain (L. paracasei CNCMI-1518) in the recovery group. Collectively, our findings show a small but measurable benefit of a fermented milk product on microbiome recovery after antibiotics, which was linked to the detection and replication of specific probiotic strains. Such functional insight can form the basis for the development of probiotic-based intervention aimed to protect gut microbiome from drug treatments.
Subject(s)
Cultured Milk Products , Gastrointestinal Microbiome , Probiotics , Anti-Bacterial Agents/therapeutic use , Feces , Humans , Probiotics/pharmacology , Probiotics/therapeutic useABSTRACT
Background: The adoption of health technologies is key to empower research participants and collect quality data. However, the acceptance of health technologies is usually evaluated in patients or healthcare practitioners, but not in clinical research participants. Methods: A 27-item online questionnaire was provided to the 11,695 members of a nutrition clinical research participant database from the Nantes area (France), to assess (1) participants' social and demography parameters, (2) equipment and usage of health apps and devices, (3) expectations in research setting and (4) opinion about the future of clinical research. Each item was described using frequency and percentage overall and by age classes. A global proportion comparison was performed using chi-square or Fisher-exact tests. Results: A total of 1529 respondents (81.0% women, 19.0% men) completed the survey. Main uses of health apps included physical activity tracking (54.7%, age-related group difference, p < 0.001) and food quality assessment (45.7%, unrelated to age groups). Overall, 20.4% of respondents declared owning a connected wristband or watch. Most participants (93.8%) expected the use of connected devices in research. However, protection of personal data (37.5%), reliability (35.5%) and skilled use of devices (28.5%) were perceived as the main barriers. Most participants (93.3%) would agree to track their food intake using a mobile app, and 80.5% would complete it for at least a week while taking part in a clinical study. Only 13.2% would devote more than 10 min per meal to such record. A majority (60.4%) of respondents would accept to share their social media posts in an anonymous way and most (82.2%) of them would accept to interact with a chatbot for research purposes. Conclusions: Our cross-sectional study suggests that clinical study participants are enthusiastic about all forms of digital health technologies and participant-centered studies but remain concerned about the use of personal data. Repeated assessments are suggested to evaluate the research participant's interest in technologies following the increase in use and demand for innovative health services during the pandemic of COVID-19.
ABSTRACT
Helicobacter pylori (Hp) eradication therapy alters gut microbiota, provoking gastrointestinal (GI) symptoms that could be improved by probiotics. The study aim was to assess the effect in Hp patients of a Test fermented milk containing yogurt and Lacticaseibacillus (L. paracasei CNCM I-1518 and I-3689, L. rhamnosus CNCM I-3690) strains on antibiotic associated diarrhea (AAD) (primary aim), GI-symptoms, gut microbiota, and metabolites. A randomised, double-blind, controlled trial was performed on 136 adults under 14-day Hp treatment, receiving the Test or Control product for 28 days. AAD and GI-symptoms were reported and feces analysed for relative and quantitative gut microbiome composition, short chain fatty acids (SCFA), and calprotectin concentrations, and viability of ingested strains. No effect of Test product was observed on AAD or GI-symptoms. Hp treatment induced a significant alteration in bacterial and fungal composition, a decrease of bacterial count and alpha-diversity, an increase of Candida and calprotectin, and a decrease of SCFA concentrations. Following Hp treatment, in the Test as compared to Control group, intra-subject beta-diversity distance from baseline was lower (padj = 0.02), some Enterobacteriaceae, including Escherichia-Shigella (padj = 0.0082) and Klebsiella (padj = 0.013), were less abundant, and concentrations of major SCFA (p = 0.035) and valerate (p = 0.045) were higher. Viable Lacticaseibacillus strains were detected during product consumption in feces. Results suggest that, in patients under Hp treatment, the consumption of a multi-strain fermented milk can induce a modest but significant faster recovery of the microbiota composition (beta-diversity) and of SCFA production and limit the increase of potentially pathogenic bacteria.
Subject(s)
Cultured Milk Products , Diarrhea/therapy , Gastrointestinal Microbiome , Helicobacter Infections/microbiology , Probiotics/administration & dosage , Adult , Aged , Anti-Bacterial Agents/adverse effects , Diarrhea/chemically induced , Diarrhea/microbiology , Double-Blind Method , Feces/microbiology , Female , Helicobacter Infections/drug therapy , Helicobacter pylori , Humans , Male , Middle Aged , Treatment Outcome , YogurtABSTRACT
BACKGROUND: Gastrointestinal (GI) discomfort is prevalent and known to be associated with impaired quality of life. Real-world information on factors of GI discomfort and solutions used by people is, however, limited. Social media, including online forums, have been considered a new source of information to examine the health of populations in real-life settings. OBJECTIVE: The aims of this retrospective infodemiology study are to identify discussion topics, characterize users, and identify perceived determinants of GI discomfort in web-based messages posted by users of French social media. METHODS: Messages related to GI discomfort posted between January 2003 and August 2018 were extracted from 14 French-speaking general and specialized publicly available online forums. Extracted messages were cleaned and deidentified. Relevant medical concepts were determined on the basis of the Medical Dictionary for Regulatory Activities and vernacular terms. The identification of discussion topics was carried out by using a correlated topic model on the basis of the latent Dirichlet allocation. A nonsupervised clustering algorithm was applied to cluster forum users according to the reported symptoms of GI discomfort, discussion topics, and activity on online forums. Users' age and gender were determined by linear regression and application of a support vector machine, respectively, to characterize the identified clusters according to demographic parameters. Perceived factors of GI discomfort were classified by a combined method on the basis of syntactic analysis to identify messages with causality terms and a second topic modeling in a relevant segment of phrases. RESULTS: A total of 198,866 messages associated with GI discomfort were included in the analysis corpus after extraction and cleaning. These messages were posted by 36,989 separate web users, most of them being women younger than 40 years. Everyday life, diet, digestion, abdominal pain, impact on the quality of life, and tips to manage stress were among the most discussed topics. Segmentation of users identified 5 clusters corresponding to chronic and acute GI concerns. Diet topic was associated with each cluster, and stress was strongly associated with abdominal pain. Psychological factors, food, and allergens were perceived as the main causes of GI discomfort by web users. CONCLUSIONS: GI discomfort is actively discussed by web users. This study reveals a complex relationship between food, stress, and GI discomfort. Our approach has shown that identifying web-based discussion topics associated with GI discomfort and its perceived factors is feasible and can serve as a complementary source of real-world evidence for caregivers.
Subject(s)
Gastrointestinal Diseases/therapy , Quality of Life/psychology , Telemedicine/methods , Adult , Female , Humans , Internet , Language , Male , Middle Aged , Retrospective Studies , Social Media , Time Factors , Young AdultABSTRACT
Food intake and usual dietary intake are among the key determinants of health to be assessed in medical research and important confounding factors to be accounted for in clinical studies. Although various methods are available for gathering dietary data, those based on innovative technologies are particularly promising. With combined cost-effectiveness and ease of use, it is safe to assume that mobile technologies can now optimize tracking of eating occasions and dietary behaviors. Yet, choosing a dietary assessment tool that meets research objectives and data quality standards remains challenging. In this paper, we describe the purposes of collecting dietary data in medical research and outline the main considerations for using mobile dietary assessment tools based on participant and researcher expectations.
Subject(s)
Biomedical Research/methods , Diet/methods , Mobile Applications/standards , Nutrition Assessment , HumansABSTRACT
In a context of rising interest in food and supplement clinical trials, operational considerations for the set-up and conduct of these research projects remain difficult to address in the absence of a harmonized referential. Food trials tend to be more pragmatic than drug trials which are usually more elucidatory. However, comparing them is difficult because the objectives they serve are different. Food trials are usually conducted to evaluate the effect of food products on the prevention or mitigation of symptoms, not the treatment or cure of a condition. In this article we explain these main differences and discuss several key operational and regulatory aspects to consider when dealing with clinical research evaluating the effect of food products on health-related biomedical or behavioral outcomes.