Batch Fermentation and Microbiome Analysis

Launched by SOCIÉTÉ DES PRODUITS NESTLÉ (SPN) · Oct 23, 2023

Keywords

ClinConnect Summary

This clinical trial, called "Batch Fermentation and Microbiome Analysis," is studying how different foods affect the bacteria in our gut, known as the microbiome, and how these bacteria can influence our health. Researchers want to see how a variety of food ingredients impact the microbiome of healthy individuals aged 0 to 60 years. Instead of asking people to eat specific foods, they will analyze fecal samples in a lab setting to simulate how the gut bacteria would react to these foods.

To participate in this trial, individuals must be healthy and between the ages of 0 and 60. Parents or guardians need to provide consent for younger participants, while those 14 and older can consent themselves. Participants will be asked to provide a fecal sample, which is a small amount of stool, to help with the study. People who follow strict diets, have certain medical conditions, or are currently taking specific medications may not be eligible to join. This study is not yet recruiting participants, so there's no immediate action needed, but it's an exciting opportunity to help researchers learn more about the connection between diet and gut health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy participant aged from 0 to 60 (based on medical history, physical examination and review of childhood growth chart)
• • Written informed consent has been obtained from the parent(s)/legally acceptable representative (LAR) of toddlers and teenagers
• • Written informed consent has been obtained for participants aged from 14 years old and above
• • Child's parent(s)/legal representative or participant is willing and able to fulfill the requirements of the study protocol.
• • Ability to collect their or their infant/child's fecal sample.
• Exclusion Criteria:
• • The parent(s)/legally acceptable representative (LAR) is not able to provide evidence of parental authority or legal representation.
• • Participant following a particular regimen of any type such as vegan, vegetarian, ketogenic, paleo diet,
• • Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily,
• • Antibacterial/antifungal therapy during the 3 months prior to study enrolment,
• • Medications or supplements that are known to alter gut function or microbiota (i.e. acid antisecretory drugs, pre-/probiotics supplements, laxatives) during the 4 weeks prior to study enrolment,
• • Prior gastrointestinal surgery (apart from appendectomy, cholecystectomy or herniotomy),
• • Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer,
• • Artificially sweetened beverage intake higher than 1000 ml/ per day,
• • Current or history of gastrointestinal diseases like (Celiac Disease, Crohn's Disease, Ulcerative colitis, Irritable Bowel Syndrome, infantile colic, recurrent abdominal pain, functional constipation, ulcers, infections (based on anamnesis),
• • Participants participating in another interventional study,
• • Participants/parents having a hierarchical or family link with the research team members.