Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 21, 2021
Date Accepted: Nov 27, 2021
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
The role of CARbohydrates in Irritable Bowel Syndrome (CARIBS): Protocol for a randomized controlled trial comparing three different treatment options
ABSTRACT
Background:
Although it is widely acknowledged that food intake can worsen symptoms in patients with irritable bowel syndrome (IBS), there is a lack of efficient treatments that are applicable to all patients and subtypes of IBS. As patients exhibit varying symptom profiles and symptomatology, it is likely that the most successful treatment option will differ among patients; therefore, this large, randomized controlled trial comparing three different treatment options for patients with IBS is highly warranted.
Objective:
A randomized controlled trial will be conducted evaluating the effectiveness of three different treatment options for patients with IBS.
Methods:
Three hundred patients with IBS will be randomized to receive one of three treatment options (1:1:1); a diet with low total carbohydrate content (LCD); a diet combining low fermentable oligo-, di-, monosaccharides and polyols (FODMAP) and traditional dietary advice (LFTD); optimized medical treatment (OMT). The study consists of a 10-day screening period, 28-days of intervention, and a 6-month follow up for patients receiving dietary treatment. Questionnaires assessing both gastrointestinal and extra-intestinal symptoms will be used as endpoints, as well as metabolomics, microbiota profiling and immunological markers. Further, qualitative methods will be used to evaluate the patient’s experiences regarding diet treatments.
Results:
Recruitment began in January 2017. By May 2021, 270 participants (90%) had been randomized and 244 participants (81%) had finished the four-week intervention. The study is still in progress and the results are expected to be published in 2022.
Conclusions:
By collecting a wide range of data before, during and after treatment in a large group of patients with IBS with diverging bowel habits, we will gain new insights in predictors of response to treatment. That information can in the future be used to personalize treatments for the patient, based on the individual’s phenotype and IBS symptoms. Also, long-term effects of two different dietary treatments will be evaluated regarding impact on gut microbiota and clinical laboratory tests, but also to ensure that they are safe, effective, and applicable to patients with IBS. Clinical Trial: This trial has been registered in ClinicalTrials.gov ID NCT02970591
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