A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome

Overview

Irritable Bowel Syndrome is a common disease to which there is no curable treatment. Diet is considered to trigger symptoms associated with the clinical picture of IBS, and dietary treatment is thus believed to relieve the symptoms of IBS. As the disease is very heterogeneous in its manifestation, different treatment options might be indicated depending on the predominant symptom. To investigate the response to different dietary treatment options, a randomized controlled intervention trial will be carried out in adult patients (>18 y) with IBS according to Rome IV criteria. The aim of this study is to compare the response to two different dietary treatments or optimized medical treatment.

Full Title of Study: “The Role of CARbohydrates in Irritable Bowel Syndrome (CARIBS): Protocol for a Randomized Controlled Trial Comparing Three Different Treatment Options”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: April 15, 2022

Detailed Description

The study is a randomized controlled trial comparing three different treatments during four weeks: 1. Combination of low FODMAP diet + traditional dietary advice (based on NICE recommendations) – Eat at regular hours; 3 main meals and 3 snacks – Eat in peace, chew the food properly – Peel all fruits and vegetables – Limit intake of spicy and fatty foods, coffe, alcohol, avoid fizzy drinks and chewing gum – Choose soluble rather than insoluble fibres – Avoid foods high in FODMAPs 2. Diet low in carbohydrates – 10 E% carbohydrates, 23 E% protein, 67 E% fat – Larger amounts of fish, shellfish, meat, egg, dairy products (lactose free if wanted) nuts, seeds, oil, vegetables – No sugary or starchy foods, e.g pasta, potatoes, bread, rice, most fruits – No specific consideration about FODMAP content 3. Optimized pharmacological tretament based on predominant symptom and previous experience with pharmacological treatmment. Pain/discomfort: – Pain: Amitriptyline 25 mg. Increase to 50 mg if needed – Episodic pain: Hyoscyamine 0,2mg 2×2; adjust dose if needed – Pain with diarrhea: Amitriptyline 25 mg. Increase dose if needed – Pain with constipation: Linaclotide 290 microgram 1×1 Constipation: – Bulking agent (Sterculia gum (Inolaxol) 1×1. Increase to 1×3 if needed – Osmotic laxative (Macrogol (Movicol) 1×1 – Linaclotide 290 microgram 1×1 Diarrhea – Loperamide 1×2 . Adjust dose if needed – Cholestyramine 1×1. Increase ever 3-5 d as needed – Ondansetron 4mg 1×1. Increase to 1×2-3 if needed – Eluxadoline 100mg 1×2 Primary endpoint: IBS-SSS reduction >50 points

Interventions

  • Other: Traditional dietary advice and low FODMAP content
    • Traditional dietary advice according to the Brittish Dietetic Association including reducing the intake of fermentable carbohydrates.
  • Other: Low carbohydrate diet
    • Diet that contains a maximum of 10 energy percent of carbohydrates, 23 energy % proteins and 67 energy % fat.
  • Other: Optimized Medical treatment
    • Standard consultation by physician and if needed patients will receive medical treatment based on the most prominent symptom. Constipation: osmotic laxatives, linaclotide. Diarrhea: loperamid, bile acid binders. Pain: anti depressent, antispasmodics, linaclotide.

Arms, Groups and Cohorts

  • Experimental: Diet A
    • Low carbohydrate diet
  • Active Comparator: Medical treatment
    • Optimized Medical treatment
  • Experimental: Diet B
    • Traditional dietary advice and low FODMAP content

Clinical Trial Outcome Measures

Primary Measures

  • The proportion (%) of patients who respond to treatment
    • Time Frame: Baseline to 4 weeks
    • A responder is defined as having an IBS-SSS reduction >50 points @ 4 weeks

Secondary Measures

  • Change in symptom severity
    • Time Frame: Baseline, 4 weeks, 3 and 6 months
    • Absolute and percentage change in IBS-SSS
  • Determinants for GI symptoms by IBS-SSS
    • Time Frame: Baseline, 4 weeks, 3 and 6 months
    • GI symptoms measured by IBS-SSS
  • Determinants for GI symptoms by GSRS-IBS
    • Time Frame: Baseline, 4 weeks, 3 and 6 months
    • GI symptoms measured by GSRS-IBS
  • Predictors of response to treatment
    • Time Frame: Baseline to 4 weeks
    • Potential predictors include demographics, questionnaire data, microbiota, metabolites, immunology
  • Adherence to allocated intervention
    • Time Frame: Baseline, 4 weeks, 3 and 6 months
    • Including compliance to dietary intervention during 4 weeks, and long-term adherence during follow-up
  • Change in microbiota content
    • Time Frame: Baseline, 4 weeks, 6 months
    • Fecal microbiota analysis using 16S technique
  • Change in extra-intestinal symptoms and quality of life
    • Time Frame: Baseline, 4 weeks, 3 and 6 months
    • As assessed by IBS specific questionnaires
  • Change in metabolic profile
    • Time Frame: Baseline, 4 weeks, 6 months
    • Metabolomics in serum and urine samples

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sahlgrenska University Hospital, Sweden
  • Provider of Information About this Clinical Study
    • Principal Investigator: Magnus Simrén, Professor – Sahlgrenska University Hospital, Sweden

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