- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04283487
Brain and Gut Responses to Intragastric Administration of FODMAPs in Healthy Subjects and Patients With Irritable Bowel Syndrome (FODMAPs)
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Leuven, Belgium, 3000
- KU Leuven
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Healthy volunteers:
Inclusion Criteria:
- 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 Criteria:
- 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
Exclusion Criteria:
General exclusion criteria for all subjects:
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 of alcohol per week)
- People who show abnormal eating behavior, or have followed a gluten-free or low-FODMAP diet previously
- Pregnant or breastfeeding women
- Claustrophobia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fructans solution
Fructans (FODMAP) are oligosaccharides containing fructose chains.
Since the human body lacks hydrolases to break down these saccharides, fructans are poorly absorbed molecules in everybody.The fructans solution used in this study is 500 ml water containing 40g fructans
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500ml 0.9% normal saline containing 40g fructans
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Active Comparator: Glucose solution
Glucose is a carbohydrate that is not classified as FODMAP, and is therefore used as a positive control in this study.
The glucose solution used in this study is 500 ml water containing 40g glucose.
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500ml 0.9% normal saline containing 40g glucose
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Placebo Comparator: Saline solution
The saline solution does't contain any sugar and used in this study is 500ml 0.9% normal saline.
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500ml 0.9% normal saline
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in brain activation patterns measured by fMRI
Time Frame: -10 min to 50 min
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change in blood oxygenation level dependent (BOLD) signal by fMRI
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-10 min to 50 min
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in gastrointestinal symptom scores measured by VAS
Time Frame: -30 min to 180 min
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bloating, nausea, cramps, flatulence and abdominal pain
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-30 min to 180 min
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Change in state emotion score measured by validated questionnaire
Time Frame: -30 min to 180 min
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emotion score measured by POMS
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-30 min to 180 min
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Change in state emotion score measured by validated questionnaire
Time Frame: -30 min to 180 min
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emotion score measured by PANAS
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-30 min to 180 min
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Change in plasma levels of gut peptides
Time Frame: -20 min to 60 min
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Plasma levels of ghrelin
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-20 min to 60 min
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Change in plasma levels of gut peptides
Time Frame: -20 min to 60 min
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Plasma levels of CCK
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-20 min to 60 min
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Change in plasma levels of gut peptides
Time Frame: -20 min to 60 min
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Plasma levels of GLP-1
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-20 min to 60 min
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Change in plasma levels of gut peptides
Time Frame: -20 min to 60 min
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Plasma levels of motilin
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-20 min to 60 min
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Change in plasma levels of gut peptides
Time Frame: -20 min to 60 min
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Plasma levels of PYY
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-20 min to 60 min
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Change in plasma levels of gut peptides
Time Frame: -20 min to 60 min
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Plasma levels of insulin
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-20 min to 60 min
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Change in plasma levels of gut peptides
Time Frame: -20 min to 60 min
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Plasma levels of glucose
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-20 min to 60 min
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Change in gut physiology measured by abdominal MRI
Time Frame: -20 min to 180 min
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Gastric emptying and accommodation, antral and small bowel motility, water and gas content measured by abdominal MRI
|
-20 min to 180 min
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Collaborators and Investigators
Investigators
- Principal Investigator: Jan Tack, MD, PHD, UZ Leuven / KU Leuven
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FODMAP2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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