Batch Fermentation and Microbiome Analysis

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06097130
• Other study ID #: 1920NR
• Status: Not yet recruiting
• Start date: January 15, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: October 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: Pamela Sun, MBBChir MPhil (Cantab)
• Phone: +41 21 785 81 22
• Email: pamela.sun[@]rd.nestle.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Switzerland	Nestle Clinical Innovation Lab	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

Switzerland, 

Outcome

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