Clinical trial NCT02970591: A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome
Official title: The Role of CARbohydrates in Irritable Bowel Syndrome (CARIBS): Protocol for a Randomized Controlled Trial Comparing Three Different Treatment Options
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: FODMAPS
carbohydrates
metabolomics
microbiota
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: The proportion (%) of patients who respond to treatment
timeFrame: Baseline to 4 weeks
Secondary outcomes:
measure: Change in symptom severity
timeFrame: Baseline, 4 weeks, 3 and 6 months
measure: Determinants for GI symptoms by IBS-SSS
timeFrame: Baseline, 4 weeks, 3 and 6 months
measure: Determinants for GI symptoms by GSRS-IBS
timeFrame: Baseline, 4 weeks, 3 and 6 months
measure: Predictors of response to treatment
timeFrame: Baseline to 4 weeks
measure: Adherence to allocated intervention
timeFrame: Baseline, 4 weeks, 3 and 6 months
measure: Change in microbiota content
timeFrame: Baseline, 4 weeks, 6 months
measure: Change in extra-intestinal symptoms and quality of life
timeFrame: Baseline, 4 weeks, 3 and 6 months
measure: Change in metabolic profile
timeFrame: Baseline, 4 weeks, 6 months
Other outcomes:
measure: Qualitative assessment
timeFrame: Approx. at 3 months follow-up
Locations:
city: Gothenburg
country: Sweden
facility: Magnus Simren
state: Non-US/Non-Canadian
Study officials:
References:
citation: Nybacka S, Tornblom H, Simren M, Storsrud S. The Role of Carbohydrates in Irritable Bowel Syndrome: Protocol for a Randomized Controlled Trial Comparing Three Different Treatment Options. JMIR Res Protoc. 2022 Jan 17;11(1):e31413. doi: 10.2196/31413.
citation: Algera JP, Storsrud S, Lindstrom A, Simren M, Tornblom H. Gluten and fructan intake and their associations with gastrointestinal symptoms in irritable bowel syndrome: A food diary study. Clin Nutr. 2021 Oct;40(10):5365-5372. doi: 10.1016/j.clnu.2021.09.002. Epub 2021 Sep 9.