HealthyNCT06097130
Batch Fermentation and Microbiome Analysis
An observational study of Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 0 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Aug 2020to 26 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy population
Who may be able to join
- 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.
Who cannot join
- 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),
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Nestle Clinical Innovation Lab
Lausanne, Canton of Vaud, 1000
About this study
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
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microbiota composition
Measured by 16s rRNA sequencing or next Generation Sequencing (NGS) or by qPCR
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Change in Short Chain Fatty Acids (SCFA)
Measured using Gas Chromatography (GC)
Measured: Through study completion, an average of 1 year
Change in metabolic profile
Measured using Gas Chromatography (GC) or Gas chromatography-mass spectrometry (GC-MS)
Measured: Through study completion, an average of 1 year
Protein expression of epithelial cells
Measured by western blot
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start18 Aug 2020
- Primary completion25 Aug 2020
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097130
- Sponsor's protocol ID
- 1920NR
- Status last verified
- Dec 2025
- First submitted
- 16 Mar 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06097130
- Acronym / sponsor ID
- 1920NR
- Conditions
- Healthy
- Keywords
- Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 0 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy population
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in microbiota composition
Time frame: Through study completion, an average of 1 year
Measured by 16s rRNA sequencing or next Generation Sequencing (NGS) or by qPCR
3 secondary outcomes
Change in Short Chain Fatty Acids (SCFA)
Time frame: Through study completion, an average of 1 year
Change in metabolic profile
Time frame: Through study completion, an average of 1 year
Protein expression of epithelial cells
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microbiota composition (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.