Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Irritable Bowel Syndrome
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

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 vege...

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, 25 E% protein, 65 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

Tracking Information

NCT #
NCT02970591
Collaborators
Not Provided
Investigators
Not Provided