The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome (NCT07439718) | Clinical Trial Compass
RecruitingNot Applicable
The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome
Switzerland25 participantsStarted 2026-02-23
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
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
Timeframe: From Baseline (Day 1) through study completion (average duration: 36 days)
2
Change in total bacterial abundance of the gut microbiota captured in fecal samples after one-month intervention with a butyric acid-rich triglyceride oil
Timeframe: From Baseline (Day 1) through study completion (average duration: 36 days)
✕. 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.
✕. 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.