Recruitment

Recruitment Status
Completed
Estimated Enrollment
40

Summary

Conditions
Irritable Bowel Syndrome
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Randomised, double-blind, placebo-controlled, crossoverMasking: Double (Participant, Investigator)Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 55 years
Gender
Only males

Description

In this study, the investigators aim to study the brain mechanisms underlying the effect of intragastric administration of one specific FODMAP (fructans) on gastrointestinal and non- gastrointestinal symptom responses, changes in gut physiology(morphology of the gut, water content and intestinal mot...

In this study, the investigators aim to study the brain mechanisms underlying the effect of intragastric administration of one specific FODMAP (fructans) on gastrointestinal and non- gastrointestinal symptom responses, changes in gut physiology(morphology of the gut, water content and intestinal motility), and to relate the findings to changes in gastrointestinal peptides. This is a randomised, double-blinded, crossover study. Eligible participants will come three times to the clinic after an overnight fast, for intragastric infusion of fructans (40g in 500 ml water), glucose(40g in 500ml water) or saline(0.9% 500ml normal saline). The infusions will be given in counterbalanced order and with a washout period of at least one week. Participants and investigators will be blinded to the nature of the test solution, which will be made by a colleague unrelated to the study. The order of the test solutions will be determined by a computer-generated list. All participants will be asked to follow the low FODMAP diet for the 24 hours prior to each study day. Participants will be asked to record their food intake during the day to check their FODMAP intakes were reduced. To begin, the participants will have a nasogastric feeding tube placed and an intravenous cannula inserted in the non-dominant arm to facilitate repeated blood sampling. Fifteen minutes later, they will enter the MR scanner for a 5 minute adaptation period. Participants will complete visual analogue scales (VAS) on appetite-related sensations and GI symptoms and blood samples will be collected for gut peptide analysis. Current emotional state will be rated before and after scanning using the PANAS, and during scanning using the POMS. The abdominal MRI scan will begin after the adaption period and will take 10 minutes. Hereafter, brain scanning will be performed, starting with a baseline brain scanning period of 10 minutes. After the baseline scanning, 500 mL of one of the three solutions will be infused as the functional brain imaging begins (and continues for 50 minutes). The VAS ratings will be collected every 10 minutes and blood samples will be collected every 20 minutes for measuring of ghrelin, CCK, GLP-1, motilin, and PYY, insulin and glucose throughout the scan. At 60 minutes post-infusion, a 10 minute abdominal scan will be acquired. After that, the subject leaves the scanner and the catheter will be removed. The subject will remain at the facility for a 2 hour follow-up during which the VAS ratings will be collected every 30 minutes and an abdominal MRI will be performed at 120 minutes post infusion. After the last abdominal MRI scan is performed, the infusion tube will be removed and the participant can go home.

Tracking Information

NCT #
NCT04283487
Collaborators
Not Provided
Investigators
Principal Investigator: Jan Tack, MD, PHD UZ Leuven / KU Leuven