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OpenTrials
Completed

NCT Number: NCT02970591

A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Magnus Simren

Gothenburg, Non-US/Non-Canadian, 44331, Sweden

About this study

The study is a randomized controlled trial comparing three different treatments during four weeks:

  • 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
  • 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
  • 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 2x2; adjust dose if needed
  • Pain with diarrhea: Amitriptyline 25 mg. Increase dose if needed
  • Pain with constipation: Linaclotide 290 microgram 1x1

Constipation:

  • Bulking agent (Sterculia gum (Inolaxol) 1x1. Increase to 1x3 if needed
  • Osmotic laxative (Macrogol (Movicol) 1x1
  • Linaclotide 290 microgram 1x1 Diarrhea
  • Loperamide 1x2 . Adjust dose if needed
  • Cholestyramine 1x1. Increase ever 3-5 d as needed
  • Ondansetron 4mg 1x1. Increase to 1x2-3 if needed
  • Eluxadoline 100mg 1x2

Primary endpoint: IBS-SSS reduction >50 points

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traditional dietary advice and low FODMAP content

Other

Traditional dietary advice according to the Brittish Dietetic Association including reducing the intake of fermentable carbohydrates.

Low carbohydrate diet

Other

Diet that contains a maximum of 10 energy percent of carbohydrates, 23 energy % proteins and 67 energy % fat.

Optimized Medical treatment

Other

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.

Primary outcomes

  1. 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 outcomes

  1. Change in symptom severity

    Time frame: Baseline, 4 weeks, 3 and 6 months

    Absolute and percentage change in IBS-SSS

  2. Determinants for GI symptoms by IBS-SSS

    Time frame: Baseline, 4 weeks, 3 and 6 months

    GI symptoms measured by IBS-SSS

  3. Determinants for GI symptoms by GSRS-IBS

    Time frame: Baseline, 4 weeks, 3 and 6 months

    GI symptoms measured by GSRS-IBS

  4. Predictors of response to treatment

    Time frame: Baseline to 4 weeks

    Potential predictors include demographics, questionnaire data, microbiota, metabolites, immunology

  5. 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

  6. Change in microbiota content

    Time frame: Baseline, 4 weeks, 6 months

    Fecal microbiota analysis using 16S technique

  7. Change in extra-intestinal symptoms and quality of life

    Time frame: Baseline, 4 weeks, 3 and 6 months

    As assessed by IBS specific questionnaires

  8. Change in metabolic profile

    Time frame: Baseline, 4 weeks, 6 months

    Metabolomics in serum and urine samples

Other outcomes

  1. Qualitative assessment

    Time frame: Approx. at 3 months follow-up

    Patient's subjective experiences related to the dietary intervention described by qualitative methods.

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Acronym: CARIBS

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Nov 22, 2016
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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