Intracolonic FODMAP Infusion in Healthy Volunteers

NCT06488534 | Completed

• 1 other identifier: S67510
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome (IBS) is one of the most common chronic diseases of the gut-brain axis. The underlying pathophysiology is multifactorial, poorly understood and differs between the subtypes: constipation-dominant IBS, diarrhea-dominant IBS, mixed IBS, and unspecified IBS. Although it is considered a motility disorder, no uniform motility patterns have been found in IBS patients and no link has yet been found between the motility patterns and the typical complaints such as nausea, fullness, cramps and flatulence. These symptoms are often diagnosed after a meal and research has shown that especially fermentable oligo, di, monosaccharides and polyols (FODMAPs) give rise to symptoms. Many studies have tested the effect of these FODMAPs after oral administration, but little is known about their direct effect on the colon. In this double-blind cross-over study, 15 healthy volunteers are subjected to 3 colonoscopies in which a catheter is placed to measure the pressures in the large intestine and to administer the dissolved FODMAPs. Volunteers will follow a diet low in fiber and FODMAPs 3 days before each study visit. In addition, they will have to record their daily bowel movements during the week of their study visit and fill in 2 short questionnaires on the day of the study visit regarding their gastrointestinal complaints. There will be at least 2 weeks between the 3 study visits to avoid any overlap between the FODMAPs.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• colonic motility

  evaluation of (high amplitude) propagating contractions, simultaneous pressure waves at 3 predefined timepoints: upon awakening, after FODMAP infusion and postprandially

  through study completion, an average of 1 year

Secondary Outcomes (6)

• abdominal symptoms

  through study completion, an average of 1 year

• stool form based on the bristol stool chart

  through study completion, an average of 1 year

• IBS-SSS and IBS-Qol

  through study completion, an average of 1 year

• microbiome

  through study completion, an average of 1 year

• colonic motor patterns by means of high resolution electrocolonography

  through study completion, an average of 1 year

Study Arms (3)

Fructose

OTHER

A solution of 10 g fructose in 200 mL of tap water will be infused once over a period of 20min. during 1 of the 3 investigation days.

Dietary Supplement: Fermentable Oligo-, Di- Monosaccharides And Polyols (FODMAPs)

Fructan

OTHER

A solution of 30 g fructan in 200 mL of tap water will be infused once over a period of 20min. during 1 of the 3 investigation days.

Dietary Supplement: Fermentable Oligo-, Di- Monosaccharides And Polyols (FODMAPs)

Mannitol

OTHER

A solution of 10 g mannitol in 200 mL of tap water will be infused once over a period of 20min. during 1 of the 3 investigation days.

Dietary Supplement: Fermentable Oligo-, Di- Monosaccharides And Polyols (FODMAPs)

Interventions

Fermentable Oligo-, Di- Monosaccharides And Polyols (FODMAPs) DIETARY_SUPPLEMENT

A FODMAP solution of 200 mL will be infused in the colon for over 20 min. via the lumen of the solid-state catheter for high-resolution colonic manometry.

Fructan; Fructose; Mannitol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• University of Auckland, New Zealand: collaborator

Study Sites (1)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

polyol

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jan Tack

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both the investigator and the participants will be blinded, which means that they will not know which of the 3 FODMAPs is administered
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mannitol, fructans and fructose will be intracolonically administered on 3 different intervestigation days with at least 2 weeks between each investigation day to avoid overlap of the different FODMAPs and to allow the colon to return to its original state

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: July 5, 2024
• Study Start: June 26, 2023
• Primary Completion: November 13, 2024
• Study Completion: December 13, 2024
• Last Updated: December 18, 2025

Record last verified: 2024-06

Locations

BE (1)