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

This study has been completed.
Sponsor:
Collaborators:
Karolinska Institutet
Aleris Specialistvård Sabbatsberg
Information provided by (Responsible Party):
Hans Törnblom, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT02107625
First received: April 4, 2014
Last updated: August 19, 2015
Last verified: August 2015
  Purpose
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.

Condition Intervention
Irritable Bowel Syndrome Behavioral: Diet A i.e. Low FODMAP diet Behavioral: Diet B, i.e. Traditional IBS diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: A Multi-centre, Randomized, Single-blind, Comparative Trial: Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients

Further study details as provided by Hans Törnblom, Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • 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.


Enrollment: 75
Study Start Date: August 2013
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Behavioral: Diet B, i.e. Traditional IBS diet

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02107625

Sponsors and Collaborators
Göteborg University
Karolinska Institutet
Aleris Specialistvård Sabbatsberg
Investigators
Principal Investigator: Hans Törnblom, MD, PhD Sahlgrenska University Hospital, Sweden
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hans Törnblom, MD, PhD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02107625     History of Changes
Other Study ID Numbers: KRIBS1
Study First Received: April 4, 2014
Last Updated: August 19, 2015

Keywords provided by Hans Törnblom, Sahlgrenska University Hospital, Sweden:
Defecation
Abdominal pain

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 23, 2017