NCT02970591·Not applicable·INTERVENTIONAL

A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome

Linaclotide Other Completed

Status

Completed

Phase

Not applicable

Enrollment

300

Locations

Results

Not posted

Publications

Study summary

What the protocol is testing.

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 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 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

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

First posted
Nov 22, 2016
Study start
Jan 2017
Primary completion
Apr 15, 2022
Study completion
Apr 29, 2022
Results posted
Not reported
Registry updated
Oct 27, 2022

Outcomes

What the study measures.

Primary outcomes

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