Status:
COMPLETED
Brain and Gut Responses to Intragastric Administration of FODMAPs in Healthy Subjects and Patients With Irritable Bowel Syndrome
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Irritable Bowel Syndrome
Eligibility:
FEMALE
18-55 years
Phase:
NA
Brief Summary
Low fermentable oligo-, di- and monosaccharides and polyols (FODMAPs) diet is taken as a possible strategy to improve symptoms in IBS patients. However, the gut-brain signalling mechanisms underlying ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Healthy volunteers:
- No symptoms or history of gastrointestinal disease or disorder, other significant diseases
- Female
- Age 18 - 55 years
- Body Mass Index (BMI) of 19 - 28 kg/m2
- Stable body weight for at least 3 months prior to the start of the study
- Right-handed or ambi-dexter
Exclusion
- Medical
- Abdominal or thoracic surgery. Exception: appendectomy
- Gastrointestinal, endocrine or neurological diseases
- Cardiovascular, respiratory, renal or urinary diseases
- Hypertension
- Food or drug allergies
- Anemia Psychiatric disorders
- Eating disorders
- Depressive disorders
- Anxiety disorders
- Psychotic disorders Medication use
- No regular medication affecting CNS or GI system (oral contraception accepted) Other
- Conditions that can interfere with functional magnetic resonance imaging (fMRI), e.g. cochlear implants, metal fragments or metal implants in the body, pacemaker, neural stimulator, …
- No history of cannabis use or any other drug of abuse for at least 12 months prior to the study
- Alcohol abuse (more than 14 units for woman per week)
- People who show abnormal eating behavior or have followed a gluten-free or low-FODMAP diet previously
- Pregnant or breastfeeding women
- Claustrophobia
- IBS patients:
- Inclusion Criteria:
- Meet the Rome IV criteria for irritable bowel syndrome (IBS)
- Patient has IBS of any subtype
- Female
- Age 18 - 55 years
- Body Mass Index (BMI) of 19 - 28 kg/m2
- Stable body weight for at least 3 months prior to the start of the study
- Right-handed or ambi-dexter
Key Trial Info
Start Date :
February 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04283487
Start Date
February 22 2018
End Date
August 10 2019
Last Update
May 28 2021
Active Locations (1)
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1
KU Leuven
Leuven, Belgium, 3000