Image

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

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

Recruiting
18-60 years
All
Phase N/A

Powered by AI

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.

Eligibility

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 details
    Microbiome Composition
    Microbiome

NCT07439718

Société des Produits Nestlé (SPN)

13 May 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.