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

Overview

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.

Interventions

• 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).

Primary outcome measures

• 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)]
• 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)]

Secondary outcome measures (9)

• 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)]

Eligibility criteria

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.
• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

Switzerland · 1 center

• Clinical Lab — Lausanne

Identifiers

NCT: NCT07439718 · 2504CLI

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗