Batch Fermentation and Microbiome Analysis

Evaluation of the Effect of Different Nutrients on the Gut Microbiota Composition and Metabolic Activity by Using in Vitro Batch Fermentation and Cellular Models

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Pamela Sun, MBBChir MPhil (Cantab); Phone Number: +41 21 785 81 22; Email: pamela.sun@rd.nestle.com
• Study Contact Backup: Name: Sylviane Oguey-Araymon; Phone Number: +41217858279; Email: sylviane.oguey-araymon@rdls.nestle.com

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1000
      • Nestle Clinical Innovation Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Healthy population

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Short Chain Fatty Acids (SCFA)	Measured using Gas Chromatography (GC)	Through study completion, an average of 1 year
Change in metabolic profile	Measured using Gas Chromatography (GC) or Gas chromatography-mass spectrometry (GC-MS)	Through study completion, an average of 1 year
Protein expression of epithelial cells	Measured by western blot	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Microbiome
• Other Study ID Numbers: 1920NR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No