A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: Traditional dietary advice and low FODMAP content; Other: Optimized Medical treatment; Other: Low carbohydrate diet

• Registration Number: NCT02970591
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief 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.

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

Study Timeline

• Study First Submitted: 2016-11-18
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-22
• Study Start: 2017-01
• Primary Completion: 2022-04-15
• Study Completion: 2022-04-29
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet A	Traditional dietary advice and low FODMAP content	Low carbohydrate diet
Medical treatment	Optimized Medical treatment	Optimized Medical treatment
Diet B	Low carbohydrate diet	Traditional dietary advice and low FODMAP content

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Magnus Simren; 🇸🇪 Gothenburg, Non-US/Non-Canadian, Sweden