Intracolonic FODMAP Infusion in Healthy Volunteers (ICOF)

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

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Fermentable Oligo-, Di- Monosaccharides And Polyols (FODMAPs)

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Fructose; 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); 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.
Other: Fructan; 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); 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.
Other: Mannitol; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
abdominal symptoms	symptoms will be registered every 15minutes during the evaluation of the colonic motility	through study completion, an average of 1 year
stool form based on the bristol stool chart	stool form differences will be evaluated during the week of the investigation (3 days before the study visit, on the day of investigation, and 3 days after the study visit)	through study completion, an average of 1 year
IBS-SSS and IBS-Qol	IBS symptom severity and influence of quality of life will be assessed at each investigation and compared between the 3 study arms.	through study completion, an average of 1 year
microbiome	a stool sample will be taken before the first study visit to evaluate the microbial composition	through study completion, an average of 1 year
colonic motor patterns by means of high resolution electrocolonography	simultaneous evaluation of colonic motor patterns with high-resolution colonic manometry and high-resolution electrocolonography	through study completion, an average of 1 year
validation of the high-resolution electrocolonography	evaluation of the high-resolution electronography als a non-invasive tool for the measurement of colonic motility	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: University of Auckland, New Zealand
• Investigators: Principal Investigator: Jan Tack, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Actual): November 13, 2024
• Study Completion (Actual): December 13, 2024

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome; polyol
• Other Study ID Numbers: S67510

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No