A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

— CARIBS  

Official title:

The Role of CARbohydrates in Irritable Bowel Syndrome (CARIBS): Protocol for a Randomized Controlled Trial Comparing Three Different Treatment Options

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970591
• Other study ID #: Car-IBS 1511-01
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: April 29, 2022

Study information

• Verified date: October 2022
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 29, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• Traditional dietary advice and low FODMAP content
Traditional dietary advice according to the Brittish Dietetic Association including reducing the intake of fermentable carbohydrates.
• Low carbohydrate diet
Diet that contains a maximum of 10 energy percent of carbohydrates, 23 energy % proteins and 67 energy % fat.
• 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.

Locations

Country	Name	City	State
Sweden	Magnus Simren	Gothenburg	Non-US/Non-Canadian

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative assessment	Patient's subjective experiences related to the dietary intervention described by qualitative methods.	Approx. at 3 months follow-up
Primary	The proportion (%) of patients who respond to treatment	A responder is defined as having an IBS-SSS reduction >50 points @ 4 weeks	Baseline to 4 weeks
Secondary	Change in symptom severity	Absolute and percentage change in IBS-SSS	Baseline, 4 weeks, 3 and 6 months
Secondary	Determinants for GI symptoms by IBS-SSS	GI symptoms measured by IBS-SSS	Baseline, 4 weeks, 3 and 6 months
Secondary	Determinants for GI symptoms by GSRS-IBS	GI symptoms measured by GSRS-IBS	Baseline, 4 weeks, 3 and 6 months
Secondary	Predictors of response to treatment	Potential predictors include demographics, questionnaire data, microbiota, metabolites, immunology	Baseline to 4 weeks
Secondary	Adherence to allocated intervention	Including compliance to dietary intervention during 4 weeks, and long-term adherence during follow-up	Baseline, 4 weeks, 3 and 6 months
Secondary	Change in microbiota content	Fecal microbiota analysis using 16S technique	Baseline, 4 weeks, 6 months
Secondary	Change in extra-intestinal symptoms and quality of life	As assessed by IBS specific questionnaires	Baseline, 4 weeks, 3 and 6 months
Secondary	Change in metabolic profile	Metabolomics in serum and urine samples	Baseline, 4 weeks, 6 months