A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 7 November 2022
• Main ID: NCT02970591
• Date of registration: 18/11/2016
• Prospective Registration: Yes
• Primary sponsor: Sahlgrenska University Hospital, Sweden
• Public title: A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome CARIBS
• Scientific title: The Role of CARbohydrates in Irritable Bowel Syndrome (CARIBS): Protocol for a Randomized Controlled Trial Comparing Three Different Treatment Options
• Date of first enrolment: January 2017
• Target sample size: 300
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02970591
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

Inclusion Criteria:

- IBS according to ROME IV criteria, BMI 18-35, ability to communicate in Swedish,
Gothenburg region resident

Exclusion Criteria:

- Heart, liver, neurologic or psychiatric disease or illness

- Serious gastrointestinal diseases

- Celiac disease

- Diabetes

- Other conditions or surgery that affects the gastrointestinal function

- Hyperlipidemia

- Food allergy or intolerance other than lactose

- Adherence to a specific diet

- Being pregnant or breastfeeding

- Previously been treated with any of the intervention arms, including having tested all
of the pharmacological treatment options of relevance for the symptom profile of the
patient



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Irritable Bowel Syndrome

Intervention(s)

Other: Traditional dietary advice and low FODMAP content

Other: Low carbohydrate diet

Other: Optimized Medical treatment

Primary Outcome(s)

The proportion (%) of patients who respond to treatment [Time Frame: Baseline to 4 weeks]

Secondary Outcome(s)

Change in metabolic profile [Time Frame: Baseline, 4 weeks, 6 months]

Change in microbiota content [Time Frame: Baseline, 4 weeks, 6 months]

Adherence to allocated intervention [Time Frame: Baseline, 4 weeks, 3 and 6 months]

Change in extra-intestinal symptoms and quality of life [Time Frame: Baseline, 4 weeks, 3 and 6 months]

Determinants for GI symptoms by IBS-SSS [Time Frame: Baseline, 4 weeks, 3 and 6 months]

Change in symptom severity [Time Frame: Baseline, 4 weeks, 3 and 6 months]

Predictors of response to treatment [Time Frame: Baseline to 4 weeks]

Determinants for GI symptoms by GSRS-IBS [Time Frame: Baseline, 4 weeks, 3 and 6 months]

Secondary ID(s)

Car-IBS 1511-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors