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Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients (KRIBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02107625
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : August 20, 2015
Sponsor:
Collaborators:
Karolinska Institutet
Aleris Specialistvård Sabbatsberg
Information provided by (Responsible Party):
Hans Törnblom, Sahlgrenska University Hospital, Sweden

Tracking Information
First Submitted Date  ICMJE April 4, 2014
First Posted Date  ICMJE April 8, 2014
Last Update Posted Date August 20, 2015
Study Start Date  ICMJE August 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2014)
Symptom alleviation through the questionnaire IBS-SSS [ Time Frame: 4 weeks ]
IBS-SSS i.e. the IBS Severity Scoring System. To assess the possible change of severity of IBS symptoms. The overall IBS score is calculated ranging from 0 to 500. A higher score implicates more severe symptom.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients
Official Title  ICMJE A Multi-centre, Randomized, Single-blind, Comparative Trial: Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients
Brief Summary The purpose of this study is to to assess if the new diet with a low-FODMAP(Fermented Oligo-, Di-, Monosaccharides And Polyols) -content yields a milder symptom picture in IBS patients compared to traditionally dietary advice in IBS. The study also aim to investigate patients compliance to either dietary advices. Further, the investigators aim to find out if IBS patients with different symptoms are alleviated in different ways, to be able to individualize the dietary advices to result in a more optimal symptom relief in each patient in the future.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • Behavioral: Diet A i.e. Low FODMAP diet
  • Behavioral: Diet B, i.e. Traditional IBS diet
Study Arms  ICMJE
  • Experimental: Diet A i.e. Low FODMAP diet
    The patients are thoroughly informed verbally and in writing how to eat according to the low FODMAP diet. The diet imply restrictions in carbohydrate intake and the patients need to follow a list with yes/no-foods for 4 weeks.
    Intervention: Behavioral: Diet A i.e. Low FODMAP diet
  • Experimental: Diet B, i.e. Traditional IBS diet
    The patients are thoroughly informed verbally and in writing how to eat according to traditional IBS dietary advices. The diet imply adapting to regular dietary habit with meals 6 times a day, no to big meals, to chew food thoroughly, to peel fruits and vegetables, no carbonated beverages, no chewing gum, no soft drinks, no sugar-free candies, or cookies. Reduce spicy foods, coffee, alcohol, onion, pulses, and fatty foods. Keep strictly to the dietary advice for 4 weeks.
    Intervention: Behavioral: Diet B, i.e. Traditional IBS diet
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2015)
75
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2014)
70
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • IBS diagnosis
  • Adult (over 18 years)
  • Be able to read/understand/write swedish

Exclusion Criteria:

  • Severe heart failure
  • Severe liver disease
  • Severe neurologic disease
  • Severe psychological disease
  • Severe gastrointestinal disease (i.e. celiac disease, IBD (inflammatory bowel disease) e.g.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02107625
Other Study ID Numbers  ICMJE KRIBS1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hans Törnblom, Sahlgrenska University Hospital, Sweden
Study Sponsor  ICMJE Göteborg University
Collaborators  ICMJE
  • Karolinska Institutet
  • Aleris Specialistvård Sabbatsberg
Investigators  ICMJE
Principal Investigator: Hans Törnblom, MD, PhD Sahlgrenska University Hospital, Sweden
PRS Account Göteborg University
Verification Date August 2015

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