Oral oil effects on the small intestine microbiome

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

This will test whether taking a daily oral oil for one month changes the gut microbiome in healthy adults aged 18 to 60.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Société des Produits Nestlé (SPN) (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Lausanne)
• Trial ID: NCT07439718 on ClinicalTrials.gov

What this trial studies

This single-center, single-arm study will enroll about 25 healthy adults to receive a one-month oral oil intervention. Participants will provide fecal samples and retrieve sampling capsules from their stool to capture small intestine microbial material. Microbiome composition before and after the intervention will be compared to identify chronic changes associated with the oil. Eligible participants must be generally healthy, have a BMI between 18.5 and under 30 kg/m2, and have no prior gastrointestinal disease or surgery.

Who should consider this trial

Good fit: Ideal candidates are healthy adults 18–60 years old with BMI 18.5–<30 kg/m2 who have no history of gastrointestinal disease or surgery and who can collect fecal samples and retrieve capsules.

Not a fit: People with prior or suspected gastrointestinal disease, prior GI surgery, BMI outside the required range, or those unwilling to collect samples or avoid diet changes are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, the intervention could show that a simple oral oil alters the small intestine microbiome and inform future nutritional or preventive strategies.

How similar studies have performed: Prior diet- and oil-based studies have shown changes in stool microbiomes, but using capsule retrieval to study chronic effects on the small intestine is relatively novel.

Eligibility criteria

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.

Where this trial is running

Lausanne

• Clinical Lab — Lausanne, Switzerland (RECRUITING)

Study contacts

• Study coordinator: Marie-Pierre Pélissou

Conditions: Microbiome Composition, Microbiome