Status:
UNKNOWN
Brain-Gut-Microbiota Interaction in IBS
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
National Research Council, Spain
Genetic Analysis AS
Conditions:
Irritable Bowel Syndrome
Functional Gastrointestinal Disorders
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Are you what you eat? How can dietary components influence microbial composition of the gut and function of the peripheral and central nervous system? The gut and brain is linked through complex mecha...
Detailed Description
Data from deep phenotype characterization of 100 patients with IBS and 40 healthy age (between 18 and 65) and gender-matched controls will be collected between May 2019 and December 2021. Psychometric...
Eligibility Criteria
Inclusion
- Subject must be between 18 and 65 years of age
- Fulfil the ROME-IV criteria for IBS
- Had recurrent abdominal pain on average at least 1 day per week during the previous 3 months that is associated with alterations in bowel habits.
- Duration at least six months.
Exclusion
- Pharmacological treatment affecting the GI-tract, including treatment for depression
- Organic disease:
- coeliac disease
- inflammatory bowel disease
- neurological diseases
- diabetes
- active helicobacter pylori infection
- polycystic ovary syndrome
- Treated with systemic antibiotics within the last 3 months
- Use painkillers regularly, other than paracetamol
- Pregnant
- Previous intestinal surgery (appendectomy is OK)
- Claustrophobic or have metallic implants that are not MR compatible
- Vegan or vegetarian
- Been travelling outside Europe within the last three weeks (or plan to travel in the nearest future)
- Probiotics or lowFODMAP-diet within the last three weeks
- Participation in any other simultaneous clinical study
- Inability to comprehend and respond to questionnaires or follow dietary guidance
Key Trial Info
Start Date :
May 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04296552
Start Date
May 20 2019
End Date
December 31 2023
Last Update
June 30 2020
Active Locations (1)
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1
Haukeland University Hospital
Bergen, Vestlandet, Norway, 5021