Efficacy of FODMAP Elimination and Subsequent Blinded Placebo-Controlled Provocations in a Randomised Controlled Study in Patients with Ulcerative Colitis in Remission and Symptoms of Irritable Bowel Syndrome: A Feasibility Study Nutrients. 2022 Mar 18;14(6):1296. doi: 10.3390/nu14061296. Dorte Melgaard 1 2, Jeanette Sørensen 3, Johannes Riis 1, Tine S Ovesen 3 4, Peter Leutscher 1 2, Suzette Sørensen 1 2, Julie K Knudsen 1, Caspar Bundgaard-Nielsen 1, Jeanette Ejstrup 3, Ann-Maria Jensen 1, Mette Borre 5, Anne L Krarup 2 3 6 |
Author information 1Centre for Clinical Research, North Denmark Regional Hospital, 9800 Hjoerring, Denmark. 2Department of Clinical Medicine, Aalborg University, 9000 Aalborg, Denmark. 3Department of Medicine, North Denmark Regional Hospital, 9800 Hjoerring, Denmark. 4Department of Clinical Nutrition, North Denmark Regional Hospital, 9800 Hjoerring, Denmark. 5Department of Hepatology and Gastroenterology, Aarhus University Hospital, 8210 Aarhus, Denmark. 6Department of Acute Medicine and Trauma Care, Aalborg University Hospital, 9000 Aalborg, Denmark. Abstract Background: Patients with inflammatory bowel disease (IBD) and symptoms of irritable bowel syndrome (IBS) may be intolerant to fermentable carbohydrates (FODMAPs). The aim of this study was to test the feasibility of eliminating and subsequently reintroducing FODMAPs in patients with IBS symptoms as part of the IBD manifestation and to compare the severity of IBS symptoms and pain, bloating and quality of life (QoL). Methods: An eight-week randomised open-label FODMAP elimination with double-blinded, crossover provocations of FODMAP and placebo. Diet patients were on a low-FODMAP diet for eight weeks with blinded two-week provocations after two and six weeks. Questionnaires, blood and stool samples were collected. Results: Patient enrolment was challenging. Nineteen participants were included in the study. Eliminating low FODMAP for two weeks resulted in significant decreases in pain and bloating scores (p < 0.003), whereas there were no statistical differences in pain scores between diet patients and controls. Pain and bloating scores increased, returning to baseline levels after two weeks of double-blinded provocations with placebo, (p > 0.05). Conclusions: The results document the possibility of performing a randomised controlled study following the gold standard for testing food intolerance with blinding of the Low FODMAP diet. Recruitment of participants was challenging.
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