A Comparison of Three Different Treatment Options for Irritable Bowel

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02970591
Study type	Interventional
Source	Sahlgrenska University Hospital, Sweden
Contact
Status	Completed
Phase	N/A
Start date	January 2017
Completion date	April 29, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome — CARIBS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms