Clinical trial NCT06097130: Batch Fermentation and Microbiome Analysis
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Healthy
Keywords: Microbiome
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2023-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy population

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.


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.

Primary outcomes:
measure: Change in microbiota composition
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Change in Short Chain Fatty Acids (SCFA)
timeFrame: Through study completion, an average of 1 year
measure: Change in metabolic profile
timeFrame: Through study completion, an average of 1 year
measure: Protein expression of epithelial cells
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Nestle Clinical Innovation Lab
state: Vaud
Study officials:
References: