Status:
COMPLETED
Batch Fermentation and Microbiome Analysis
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Healthy
Eligibility:
All Genders
Up to 60 years
Brief Summary
The correlation between diet and microbiota as well as the effect of microbiota on human health is well established. Studies have shown that people following specific diets have different microbiome p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 26 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06097130
Start Date
August 18 2020
End Date
March 26 2025
Last Update
December 18 2025
Active Locations (1)
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1
Nestle Clinical Innovation Lab
Lausanne, Canton of Vaud, Switzerland, 1000