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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diet A i.e. Low FODMAP diet
Diet B, i.e. Traditional IBS diet
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Defecation, Abdominal pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Diet A i.e. Low FODMAP diet

    Diet B, i.e. Traditional IBS diet

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Symptom alleviation through the questionnaire IBS-SSS
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 4, 2014
    Last Updated
    August 19, 2015
    Sponsor
    Göteborg University
    Collaborators
    Karolinska Institutet, Aleris Specialistvård Sabbatsberg
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02107625
    Brief Title
    Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients
    Acronym
    KRIBS
    Official Title
    A Multi-centre, Randomized, Single-blind, Comparative Trial: Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2013 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Göteborg University
    Collaborators
    Karolinska Institutet, Aleris Specialistvård Sabbatsberg

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome
    Keywords
    Defecation, Abdominal pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    75 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diet A i.e. Low FODMAP diet
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Diet B, i.e. Traditional IBS diet
    Arm Type
    Experimental
    Arm Description
    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 Type
    Behavioral
    Intervention Name(s)
    Diet A i.e. Low FODMAP diet
    Intervention Type
    Behavioral
    Intervention Name(s)
    Diet B, i.e. Traditional IBS diet
    Primary Outcome Measure Information:
    Title
    Symptom alleviation through the questionnaire IBS-SSS
    Description
    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.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hans Törnblom, MD, PhD
    Organizational Affiliation
    Sahlgrenska University Hospital, Sweden
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34634050
    Citation
    Nybacka S, Simren M, Storsrud S, Tornblom H, Winkvist A, Lindqvist HM. Changes in serum and urinary metabolomic profile after a dietary intervention in patients with irritable bowel syndrome. PLoS One. 2021 Oct 11;16(10):e0257331. doi: 10.1371/journal.pone.0257331. eCollection 2021.
    Results Reference
    derived
    PubMed Identifier
    30838348
    Citation
    Nybacka S, Storsrud S, Liljebo T, Le Neve B, Tornblom H, Simren M, Winkvist A. Within- and Between-Subject Variation in Dietary Intake of Fermentable Oligo-, Di-, Monosaccharides, and Polyols Among Patients with Irritable Bowel Syndrome. Curr Dev Nutr. 2018 Dec 24;3(2):nzy101. doi: 10.1093/cdn/nzy101. eCollection 2019 Feb.
    Results Reference
    derived
    PubMed Identifier
    28416515
    Citation
    Bennet SMP, Bohn L, Storsrud S, Liljebo T, Collin L, Lindfors P, Tornblom H, Ohman L, Simren M. Multivariate modelling of faecal bacterial profiles of patients with IBS predicts responsiveness to a diet low in FODMAPs. Gut. 2018 May;67(5):872-881. doi: 10.1136/gutjnl-2016-313128. Epub 2017 Apr 17.
    Results Reference
    derived
    PubMed Identifier
    26255043
    Citation
    Bohn L, Storsrud S, Liljebo T, Collin L, Lindfors P, Tornblom H, Simren M. Diet low in FODMAPs reduces symptoms of irritable bowel syndrome as well as traditional dietary advice: a randomized controlled trial. Gastroenterology. 2015 Nov;149(6):1399-1407.e2. doi: 10.1053/j.gastro.2015.07.054. Epub 2015 Aug 5.
    Results Reference
    derived

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

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