Microbiome CompositionNCT07439718
The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome
A study testing Oil in people with Microbiome Composition and Microbiome, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
This is a single-center, single-arm study, aiming at enrolling 25 healthy adult participants to evaluate chronic effects of oil. Specifically, we aim to assess the impact on gut microbiome after a one-month intervention with oil. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiome Composition, Microbiome
- What is being tested?
- Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Feb 2026to 28 May 2026
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females aged 18 to 60 years, inclusive, at enrollment.
- BMI of ≥18.5 but <30 kg/m2.
- Healthy, as determined based on self-reported medical history.
- No planned change in diet or medical interventions during the study.
- Willing to collect fecal samples and retrieve sampling capsules from feces.
- Able to understand and to sign a written informed consent prior to study enrollment.
- Willing and able to comply with the requirements for participation in this study.
Who cannot join
- Prior or suspected gastrointestinal disease (as reported by the participant) which, in the investigator/study doctor's opinion, would lead to fistula formation, intestinal stricturing, or obstruction leading to a risk of capsule non-excretion (i.e. achalasia, active ulcer disease, eosinophilic esophagitis, Crohn's disease, ulcerates colitis, celiac disease, irritable bowel syndrome, stenosis of the GI tract).
- Any prior gastrointestinal surgery (as reported by the participant) which, in the investigator/study doctor's opinion, would lead to intestinal stricturing or obstruction leading to a risk of capsule non-excretion (i.e. previous esophageal, gastric, small intestinal, or colonic surgery). Note: appendectomy, cholecystectomy, hysterectomy, oophorectomy, hemorrhoid surgery more than 3 months prior to enrollment are acceptable.
- History of chronic diarrhea (defined as Bristol stool scale 5 to 7; or persistent or recurrent loose or watery stools lasting for more than 4 weeks), as reported by the participant.
- History of chronic constipation (defined as having less than 3 bowel movements per week) in the past month, as reported by the participant.
- Any history of obstructive symptoms in the previous 3 months prior to enrollment, as reported by the participant.
- Diagnosis of any organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome, as reported by the participant.
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- Diagnosis of any malabsorption disorder (i.e. malabsorption syndrome, lactose malabsorption), as reported by the participant.
- History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule, as reported by the participant.
- Any concurrent cancer diagnosis, as reported by the participant.
- Any cancer treatment within the past year, as reported by the participant.
- History of known abdominal or pelvic radiation treatment at any time in the past, as reported by the participant.
- Any cardiovascular, endocrine, renal, liver, or other chronic disease likely to affect motility (i.e. diabetes mellitus, concurrent biliary tract stones, kidney stones, etc.), as reported by the participant.
- Antibacterial/antifungal therapy in the past 3 months prior to enrolment, as reported by the participant.
- Use of any medications or supplements that could substantially alter gastrointestinal acidity, motor function, or microbiota (e.g. proton pump inhibitors, H2 receptor antagonists, opioids, prokinetics, anticholinergics, laxatives) in the past 4 weeks prior to enrollment, as reported by the participant.
- Underwent colon cleanse or bowel preparation in the 2 weeks prior to enrollment, as reported by the participant.
- Scheduled for an MRI at any time during the study duration. Potential participants may be eligible to participate once their MRI procedure is completed.
- Females of childbearing age who are pregnant or lactating, as reported by the participant (should an X-ray be required for confirmation of capsule passage; a urine pregnancy test will be administered beforehand).
- Alcohol intake higher than 2 servings per day over a week (for males), or more than 1 serving per day over a week (for females), as reported by the participant. A serving is 0.3 dl of strong alcohol, 1 dl of wine, or 3 dl of beer.
- Currently participating in another interventional study.
- Family or hierarchical relationships with the research team members.
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-center, single-arm study, aiming at enrolling 25 healthy adult participants to evaluate chronic effects of oil. Specifically, we aim to assess the impact on gut microbiome after a one-month intervention with oil.
- Conditions
- Microbiome Composition, Microbiome
- Being tested
- Oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OilDietary supplement
The investigational product will be taken orally (10mL) once a day for the duration of 28 days (up to a maximum of 37 days).
| Study group | Role | What they receive |
|---|---|---|
| Interventional Product Arm - butyric acid-rich triglyceride oil | Experimental | Butyric acid-rich triglyceride oil, commercially available Receives: Dietary Supplement: Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total bacterial abundance of the gut microbiota captured in small intestinal fluid after one-month intervention with a butyric acid-rich triglyceride oil
We aim to identify changes in the gut microbiome composition after chronic oil ingestion (one-month intervention)
Measured: From Baseline (Day 1) through study completion (average duration: 36 days)
Change in total bacterial abundance of the gut microbiota captured in fecal samples after one-month intervention with a butyric acid-rich triglyceride oil
We aim to identify changes in the gut microbiome composition after chronic oil ingestion (one-month intervention)
Measured: From Baseline (Day 1) through study completion (average duration: 36 days)
Secondary outcomes (9)
Change in butyrate levels in the small intestinal fluid after acute ingestion of the butyric acid-rich triglyceride oil.
To assess the release of butyrate in the small intestine after acute ingestion of the butyric acid-rich triglyceride oil.
Measured: From Baseline (Day 1) to Day 8 (after first ingestion of IP)
Change in absolute amount of various lipid classes (e.g. triglycerides, fatty acids, etc.) in the small intestinal fluid after acute ingestion of the butyric acid-rich triglyceride oil.
To assess the change in lipids metabolism in the small intestine after acute ingestion of the butyric acid-rich triglyceride oil.
Measured: From Baseline (Day 1) to Day 8 (after first ingestion of IP)
Change in butyrate levels in the plasma EDTA after acute ingestion of the butyric acid-rich triglyceride oil.
To assess the release of butyrate in the small intestine measured through the absorption in the bloodstream after acute ingestion of the butyric acid-rich triglyceride oil.
Measured: Day 8 (before and after ingestion of IP)
Change in ketone bodies levels in the plasma EDTA after acute ingestion of the butyric acid-rich triglyceride oil.
To assess the release of ketone bodies in the small intestine measured through the absorption in the bloodstream after acute ingestion of the butyric acid-rich triglyceride oil.
Measured: Day 8 (before and after ingestion of IP)
Change in total bacterial abundance of the microbiota of saliva after one-month intervention with butyric acid-rich triglyceride oil.
To identify changes in the oral microbiome composition after one-month intervention with butyric acid-rich triglyceride oil.
Measured: From Baseline (Day 1) through study completion (average duration: 36 days)
Change in total GSRS scores after one-month intervention with butyric acid-rich triglyceride oil
To assess the tolerability of butyric acid-rich triglyceride oil intake.
Measured: From Baseline (Day 1) through study completion (average duration: 36 days)
Change in GSRS scores in each of the 5 domains (reflux, abdominal pain, indigestion, diarrhea, constipation) after one-month intervention with butyric acid-rich triglyceride oil
To assess the tolerability of butyric acid-rich triglyceride oil intake.
Measured: From Baseline (Day 1) through study completion (average duration: 36 days)
Change in the Bristol stool scale after one-month intervention with butyric acid-rich triglyceride oil
To assess the tolerability of butyric acid-rich triglyceride oil intake.
Measured: From Baseline (Day 1) through study completion (average duration: 36 days)
Ease of retrieval of capsules based on participant feedback
Participants will be asked to provide feedback on the ease of retreival of capsule through a simple questionnaire, and this will be used to assess the feasibility of incorporating the use of the SIMBA capsule in clinical trials.
Measured: From Baseline (Day 1) through study completion (average duration: 36 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start23 Feb 2026
- Primary completion28 May 2026
- Study completion28 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbiome CompositionStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT07439718
- Sponsor's protocol ID
- 2504CLI
- Status last verified
- Apr 2026
- First submitted
- 23 Jan 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome
- ClinicalTrials.gov ID
- NCT07439718
- Acronym / sponsor ID
- 2504CLI
- Conditions
- Microbiome Composition, Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 27 Feb 2026 (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.
This is a single-center, single-arm study, aiming at enrolling 25 healthy adult participants to evaluate chronic effects of oil. Specifically, we aim to assess the impact on gut microbiome after a one-month intervention with oil.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Product Arm - butyric acid-rich triglyceride oil | Experimental | Dietary Supplement: OilButyric acid-rich triglyceride oil, commercially available |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males or females aged 18 to 60 years, inclusive, at enrollment.
- BMI of ≥18.5 but <30 kg/m2.
- Healthy, as determined based on self-reported medical history.
- No planned change in diet or medical interventions during the study.
- Willing to collect fecal samples and retrieve sampling capsules from feces.
Key exclusion criteria (20 listed)
- Prior or suspected gastrointestinal disease (as reported by the participant) which, in the investigator/study doctor's opinion, would lead to fistula formation, intestinal stricturing, or obstruction leading to a risk of capsule non-excretion (i.e. achalasia, active ulcer disease, eosinophilic esophagitis, Crohn's disease, ulcerates colitis, celiac disease, irritable bowel syndrome, stenosis of the GI tract).
- Any prior gastrointestinal surgery (as reported by the participant) which, in the investigator/study doctor's opinion, would lead to intestinal stricturing or obstruction leading to a risk of capsule non-excretion (i.e. previous esophageal, gastric, small intestinal, or colonic surgery). Note: appendectomy, cholecystectomy, hysterectomy, oophorectomy, hemorrhoid surgery more than 3 months prior to enrollment are acceptable.
- History of chronic diarrhea (defined as Bristol stool scale 5 to 7; or persistent or recurrent loose or watery stools lasting for more than 4 weeks), as reported by the participant.
- History of chronic constipation (defined as having less than 3 bowel movements per week) in the past month, as reported by the participant.
- Any history of obstructive symptoms in the previous 3 months prior to enrollment, as reported by the participant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OilThe investigational product will be taken orally (10mL) once a day for the duration of 28 days (up to a maximum of 37 days). | Dietary supplement | Interventional Product Arm - butyric acid-rich triglyceride oil |
Primary outcome
Change in total bacterial abundance of the gut microbiota captured in small intestinal fluid after one-month intervention with a butyric acid-rich triglyceride oil
Time frame: From Baseline (Day 1) through study completion (average duration: 36 days)
We aim to identify changes in the gut microbiome composition after chronic oil ingestion (one-month intervention)
Change in total bacterial abundance of the gut microbiota captured in fecal samples after one-month intervention with a butyric acid-rich triglyceride oil
Time frame: From Baseline (Day 1) through study completion (average duration: 36 days)
We aim to identify changes in the gut microbiome composition after chronic oil ingestion (one-month intervention)
9 secondary outcomes
Change in butyrate levels in the small intestinal fluid after acute ingestion of the butyric acid-rich triglyceride oil.
Time frame: From Baseline (Day 1) to Day 8 (after first ingestion of IP)
Change in absolute amount of various lipid classes (e.g. triglycerides, fatty acids, etc.) in the small intestinal fluid after acute ingestion of the butyric acid-rich triglyceride oil.
Time frame: From Baseline (Day 1) to Day 8 (after first ingestion of IP)
Change in butyrate levels in the plasma EDTA after acute ingestion of the butyric acid-rich triglyceride oil.
Time frame: Day 8 (before and after ingestion of IP)
Change in ketone bodies levels in the plasma EDTA after acute ingestion of the butyric acid-rich triglyceride oil.
Time frame: Day 8 (before and after ingestion of IP)
Change in total bacterial abundance of the microbiota of saliva after one-month intervention with butyric acid-rich triglyceride oil.
Time frame: From Baseline (Day 1) through study completion (average duration: 36 days)
Change in total GSRS scores after one-month intervention with butyric acid-rich triglyceride oil
Time frame: From Baseline (Day 1) through study completion (average duration: 36 days)
Change in GSRS scores in each of the 5 domains (reflux, abdominal pain, indigestion, diarrhea, constipation) after one-month intervention with butyric acid-rich triglyceride oil
Time frame: From Baseline (Day 1) through study completion (average duration: 36 days)
Change in the Bristol stool scale after one-month intervention with butyric acid-rich triglyceride oil
Time frame: From Baseline (Day 1) through study completion (average duration: 36 days)
Ease of retrieval of capsules based on participant feedback
Time frame: From Baseline (Day 1) through study completion (average duration: 36 days)
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 17 Sep 2026.
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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?
A study testing Oil in people with Microbiome Composition and Microbiome, 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 7 inclusion and 20 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 17 Sep 2026. 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 total bacterial abundance of the gut microbiota captured in small intestinal fluid after one-month intervention with a butyric acid-rich triglyceride oil (time frame: From Baseline (Day 1) through study completion (average duration: 36 days)). The study lists 2 primary outcomes in all. 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 17 Sep 2026.