The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome

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 Overview

• Status: Recruiting
• Conditions: Microbiome; Microbiome Composition
• Intervention / Treatment: Dietary supplement: Oil

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Pierre Pélissou; Phone Number: +41 21 785 86 39; Email: marie-pierre.pelissou@rd.nestle.com

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1000
    • Recruiting
    • Clinical Lab
    • Contact: Ambra Giorgetti; Phone Number: +41763163505; Email: ambra.giorgetti@rd.nestle.com
    • Principal Investigator: Carolina Stambolsky, Dr.
    • Sub-Investigator: Ambra Giorgetti, PhD.

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Males or females aged 18 to 60 years, inclusive, at enrollment.
2. BMI of ≥18.5 but <30 kg/m2.
3. Healthy, as determined based on self-reported medical history.
4. No planned change in diet or medical interventions during the study.
5. Willing to collect fecal samples and retrieve sampling capsules from feces.
6. Able to understand and to sign a written informed consent prior to study enrollment.
7. Willing and able to comply with the requirements for participation in this study.

Exclusion Criteria:

1. 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).
2. 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.
3. 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.
4. History of chronic constipation (defined as having less than 3 bowel movements per week) in the past month, as reported by the participant.
5. Any history of obstructive symptoms in the previous 3 months prior to enrollment, as reported by the participant.
6. Diagnosis of any organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome, as reported by the participant.
7. Diagnosis of any malabsorption disorder (i.e. malabsorption syndrome, lactose malabsorption), as reported by the participant.
8. History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule, as reported by the participant.
9. Any concurrent cancer diagnosis, as reported by the participant.
10. Any cancer treatment within the past year, as reported by the participant.
11. History of known abdominal or pelvic radiation treatment at any time in the past, as reported by the participant.
12. 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.
13. Antibacterial/antifungal therapy in the past 3 months prior to enrolment, as reported by the participant.
14. 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.
15. Underwent colon cleanse or bowel preparation in the 2 weeks prior to enrollment, as reported by the participant.
16. Scheduled for an MRI at any time during the study duration. Potential participants may be eligible to participate once their MRI procedure is completed.
17. 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).
18. 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.
19. Currently participating in another interventional study.
20. Family or hierarchical relationships with the research team members.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Product Arm - butyric acid-rich triglyceride oil; Butyric acid-rich triglyceride oil, commercially available	Dietary supplement: Oil; The investigational product will be taken orally (10mL) once a day for the duration of 28 days (up to a maximum of 37 days).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	From Baseline (Day 1) through study completion (average duration: 36 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	From Baseline (Day 1) through study completion (average duration: 36 days)

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lipids; Oils
• Other Study ID Numbers: 2504CLI

Drug and device information, study documents

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