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A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome (Car-IBS)

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ClinicalTrials.gov Identifier: NCT02970591
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Magnus Simrén, Sahlgrenska University Hospital, Sweden

Tracking Information
First Submitted Date  ICMJE November 18, 2016
First Posted Date  ICMJE November 22, 2016
Last Update Posted Date September 23, 2019
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2017)
Change in IBS-SSS [ Time Frame: Baseline, 4 weeks, 3 and 6 months ]
Primary endpoint: IBS-SSS reduction >50 points @ 4 weeks
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2016)
Change in IBS-SSS [ Time Frame: Baseline, 4 weeks, 3 and 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2017)
  • Change in metabolic profile [ Time Frame: Baseline, 4 weeks, 6 months ]
    Metabolomics in urine samples
  • Change in microbiota content [ Time Frame: Baseline, 4 weeks, 6 months ]
    Fecal microbiota analysis using 16S technique
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2016)
  • Change in metabolic profile [ Time Frame: Baseline, 4 weeks, 6 months ]
  • Change in microbiota content [ Time Frame: Baseline, 4 weeks, 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome
Official Title  ICMJE A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome; Traditional Dietary Advice Including Low FODMAP Content, vs a Low Carbohydrate Diet vs Optimized Medical Treatment for Adult Patients With IBS.
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 III 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, 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
  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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • 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, 25 energy % proteins and 65 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.
Study Arms  ICMJE
  • Experimental: Diet B
    Low carbohydrate diet
    Intervention: Other: Low carbohydrate diet
  • Active Comparator: Medical treatment
    Optimized Medical treatment
    Intervention: Other: Optimized Medical treatment
  • Experimental: Diet A
    Traditional dietary advice and low FODMAP content
    Intervention: Other: Traditional dietary advice and low FODMAP content
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2016)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • IBS according to ROME III criteria, BMI 18-35, ability to communicate on Swedish

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02970591
Other Study ID Numbers  ICMJE Car-IBS 1511-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Magnus Simrén, Sahlgrenska University Hospital, Sweden
Study Sponsor  ICMJE Sahlgrenska University Hospital, Sweden
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sahlgrenska University Hospital, Sweden
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP