The Effects of FODMAPs in Patients With Irritable Bowel Syndrome
Launched by SAHLGRENSKA UNIVERSITY HOSPITAL · Dec 20, 2021
Trial Information
Current as of August 31, 2025
Completed
Keywords
ClinConnect Summary
The study is a randomized, double-blind, cross-over trial.
The aim is to assess the effects of low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet compared to moderate/high FODMAP diet in IBS patients on gastrointestinal symptoms and psychological factors. The primary hypothesis is that the low FODMAP diet decreases gastrointestinal symptoms compared to moderate/high FODMAP diet, and that this change is accompanied with reduced psychological distress.
IBS patients (Rome IV) are challenged with FODMAPs in this randomized, double-blinded, cross-over st...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adult patients with IBS according to Rome IV criteria
- Exclusion Criteria:
- • allergy or documented intolerance to food
- • severe cardiovascular disease
- • severe hepatic disease
- • severe neurological disease
- • severe psychiatric disease
- • celiac disease
- • inflammatory bowel diseases
- • diabetes
- • bowel dysfunction related to previous surgery
- • pregnant or lactating women
- • use of antibiotics within four weeks before inclusion
- • strict avoidance of foods
About Sahlgrenska University Hospital
Sahlgrenska University Hospital, a leading healthcare institution in Sweden, is at the forefront of clinical research and innovation. Affiliated with the University of Gothenburg, the hospital integrates advanced medical care with cutting-edge research, facilitating a collaborative environment for scientific exploration and clinical trials. With a commitment to improving patient outcomes, Sahlgrenska University Hospital focuses on a wide range of therapeutic areas, leveraging its multidisciplinary expertise to advance healthcare solutions. The institution is dedicated to fostering ethical research practices and ensuring the highest standards of patient safety and care in all clinical trials.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Gothenburg, Non Us/Non Canadian, Sweden
Gothenburg, , Sweden
Patients applied
Trial Officials
Magnus Simrén, Professor
Principal Investigator
Göteborg University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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