Irritable Bowel SyndromeICOFNCT06488534
Intracolonic FODMAP Infusion in Healthy Volunteers
A study testing Fermentable Oligo-, Di- Monosaccharides And Polyols (FODMAPs) in people with Irritable Bowel Syndrome, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Fermentable Oligo-, Di- Monosaccharides And Polyols (FODMAPs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Jun 2023to 13 Dec 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Fermentable Oligo-, Di- Monosaccharides And Polyols (FODMAPs)
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Fermentable Oligo-, Di- Monosaccharides And Polyols (FODMAPs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
colonic motility
evaluation of (high amplitude) propagating contractions, simultaneous pressure waves at 3 predefined timepoints: upon awakening, after FODMAP infusion and postprandially
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
abdominal symptoms
symptoms will be registered every 15minutes during the evaluation of the colonic motility
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start26 Jun 2023
- Primary completion13 Nov 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University of Auckland, New Zealand
- Responsible party
- Sponsor
- Investigators
- Jan Tack, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488534
- Sponsor's protocol ID
- S67510
- Acronym
- ICOF
- Status last verified
- Jun 2024
- First submitted
- 12 Sep 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No