Infusion of FODMAPs in the colon of healthy volunteers

The Effect of Intracolonic Infusion of FODMAPS on Colonic Motility and Symptoms in Healthy Volunteers

This study is testing how infusing certain sugars into the colon affects gut pressure and symptoms in healthy people to better understand triggers for irritable bowel syndrome.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Universitaire Ziekenhuizen KU Leuven (Academic / other)
• Locations: 1 site (Leuven, Vlaams-Brabant)
• Trial ID: NCT06488534 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of fermentable oligo-, di-, monosaccharides, and polyols (FODMAPs) directly infused into the colon of healthy volunteers. It aims to understand the impact of these substances on gastrointestinal pressures and symptoms associated with irritable bowel syndrome (IBS). The study employs a double-blind, cross-over design involving three colonoscopies for each participant to measure the physiological responses. By focusing on the direct effects of FODMAPs in the colon, the research seeks to fill gaps in current knowledge regarding IBS and its triggers.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy volunteers who consider themselves in good health and can comply with study requirements.

Not a fit: Patients with a history of major gastrointestinal surgery or those with existing gastrointestinal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the mechanisms of IBS and lead to better dietary recommendations for managing symptoms.

How similar studies have performed: While many studies have explored the effects of FODMAPs through oral administration, this approach of direct colon infusion is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Subjects should provide written informed consent to participate in the study
* Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 years without spontaneous menses.
* Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements.
* Healthy volunteers should consider themselves healthy and should not be medically examined

Exclusion Criteria:

* History of major surgery of the gastrointestinal tract (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed).
* Known underlying organic gastrointestinal disease, including intestinal obstruction, ileus, intestinal perforation, severe inflammatory disorder like ulcerative colitis, Crohn's disease or toxic megacolon
* Diabetes mellitus types 1 and 2
* Concomitant Kidney or Liver disease, Biliary obstruction
* Decreased cardiac -or respiratory function
* Pregnant or breastfeeding women
* Use of antibiotics in the past month
* History of skin allergies or a history of extreme sensitivity to cosmetics or lotions
* Fragile skin vulnerable to skin tears.
* Damaged epigastric skin (open wounds, rash, inflammation)
* Subjects who are unable to remain in a relaxed reclined position for the test duration
* Subject has received an investigational drug or used an investigational medical device within 30 days prior to randomization, or is currently enrolled in an investigational study.
* The use of following drugs 1 month prior to inclusion and during the whole study duration: laxatives, opioids, anti-acids, anticholinergics/antispasmodics, anticonvulsants, antidepressants, diuretics, antihypertensives, antipsychotics, calcium channel blockers, bile acid sequestrants, iron supplements, anticoagulants, HIV protease inhibitors (saquinavir, lopinavir), atorvastatine, negazodone, efavirenz, Sint-janskruid (CYP3A4 inducers)

Where this trial is running

Leuven, Vlaams-Brabant

• KU Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)

Study contacts

• Principal investigator: Jan Tack — Universitaire Ziekenhuizen KU Leuven
• Study coordinator: Annelies Verheyden

Conditions Irritable Bowel Syndrome