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| Name | Class |
|---|---|
| University of Auckland, New Zealand | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Tack | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KU Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C024617 | polyol |
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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
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Both the investigator and the participants will be blinded, which means that they will not know which of the 3 FODMAPs is administered
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 |
| D004066 | Digestive System Diseases |