Batch Fermentation and Microbiome Analysis

NCT ID: NCT06097130

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-18
• Study Completion Date: 2025-03-26

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 profile compared to those following traditional or ordinary diets. In order to screen several food ingredients for their effects on human microbiota composition and metabolic activities, in vitro studies are proposed. Nutrients are added in-vitro in fecal sample, eliminating the need for participants to consume any nutritional product. The batch fermentation in vitro system simulates human colonic microbiota from fecal samples, enabling the complex mixture of microorganisms. This system could serve as a simple model to simulate the diversity as well as the metabolism of human colonic microbiota. We will evaluate the effect on nutrient/s on the age specific microbiome via an in vitro fermentation approach for the 0 to 60 year-old period.

Conditions

Healthy

Keywords

Microbiome

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nestle Clinical Innovation Lab

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

1920NR

Identifier Type: -

Identifier Source: org_study_id