Batch Fermentation and Microbiome Analysis

NCT06097130 | Completed

• 1 other identifier: 1920NR
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in microbiota composition

  Measured by 16s rRNA sequencing or next Generation Sequencing (NGS) or by qPCR

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Change in Short Chain Fatty Acids (SCFA)

  Through study completion, an average of 1 year

• Change in metabolic profile

  Through study completion, an average of 1 year

• Protein expression of epithelial cells

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: 0 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy population

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Nestle Clinical Innovation Lab

Lausanne, Canton of Vaud, 1000, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: October 24, 2023
• Study Start: August 18, 2020
• Primary Completion: August 25, 2020
• Study Completion: March 26, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)