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Gluten-free Diet in Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gluten-free diet
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients aged 16 years or over
  2. Patients fulfilling ROME III symptom based criteria for IBS-D but do not have coeliac disease

Exclusion Criteria:

  1. Patients diagnosed with coeliac disease
  2. Patients already on a gluten-free diet
  3. Patients initially referred with self-reported gluten sensitivity
  4. Patients with organic conditions that can mimic IBS-D such as idiopathic bile acid diarrhoea, pancreatic insufficiency, microscopic colitis, and inflammatory bowel disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    At-risk serology

    Not at-risk serology

    Arm Description

    Gluten-free diet

    Gluten-free diet

    Outcomes

    Primary Outcome Measures

    Irritable Bowel Syndrome Symptom Severity Scores. This validated questionaire will be self-completed at baseline and at week 6. The investigators will compare the changes in scores over this time point.

    Secondary Outcome Measures

    Hospital Anxiety and Depression scores. This validated questionaire will be self-completed at baseline and at week 6. The investigators will compare the changes in scores over this time point.
    Fatigue Impact Scores. This validated questionaire will be self-completed at baseline and at week 6. The investigators will compare the changes in scores over this time point.
    Short-form 36 Quality of Life Scores. This validated questionaire will be self-completed at baseline and at week 6. The investigators will compare the changes in scores over this time point.
    Assess whether patients opt to continue with a GFD of their own volition
    At the end of the six-week GFD trial period, patients will be asked whether or not they plan to continue with a GFD of their own volition. This will be assessed by a "yes/no" answer. Those who choose to do so will now be followed-up under routine clinical care over the next 1-2 years. This will allow the investigators to assess whether symptom-remission is maintained by using the same questionnaires mentioned in outcomes 1 to 4. It will also allow the investigators to monitor well-being in the form of body-mass index and serum haematinics (vitamin B12, folate, ferritin, albumin, haemoglobin).

    Full Information

    First Posted
    August 18, 2015
    Last Updated
    April 2, 2019
    Sponsor
    Sheffield Teaching Hospitals NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02528929
    Brief Title
    Gluten-free Diet in Irritable Bowel Syndrome
    Official Title
    Assessing the Clinical Response to a Gluten Free Diet in Patients With Diarrhoea Predominant Irritable Bowel Syndrome, in Whom Overt Coeliac Disease Has Been Excluded
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    July 31, 2018 (Actual)
    Study Completion Date
    November 13, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sheffield Teaching Hospitals NHS Foundation Trust

    4. Oversight

    5. Study Description

    Brief Summary
    To evaluate the effects of a gluten-free diet in irritable bowel syndrome.
    Detailed Description
    Irritable bowel syndrome with diarrhoea (IBS-D) is commonly encountered in primary and secondary-care practice. There are various triggers including diet. There is a growing number of people taking a gluten-free diet (GFD) of their own volition even in the absence of coeliac disease (CD). The investigators aim to assess whether a GFD could be of benefit to patients with IBS-D, previously naive to the effects of gluten and in whom CD has been excluded as per normal duodenal biopsies. The investigators will also assess whether certain factors may predict a clinical responder such as the presence or absence of at-risk coeliac serology.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    At-risk serology
    Arm Type
    Active Comparator
    Arm Description
    Gluten-free diet
    Arm Title
    Not at-risk serology
    Arm Type
    Active Comparator
    Arm Description
    Gluten-free diet
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Gluten-free diet
    Intervention Description
    Patients with IBS-D will commence a gluten-free diet for 6 weeks following dietetic input. They will be informed they do not have coeliac disease. They will however be blinded to whether or not they have any markers of at-risk serology. They will self-complete validated questionnaires over 6 weeks. Any subjects who opt to continue with a gluten-free diet thereafter of their own volition will be kept under observation as per routine clinical care.
    Primary Outcome Measure Information:
    Title
    Irritable Bowel Syndrome Symptom Severity Scores. This validated questionaire will be self-completed at baseline and at week 6. The investigators will compare the changes in scores over this time point.
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Hospital Anxiety and Depression scores. This validated questionaire will be self-completed at baseline and at week 6. The investigators will compare the changes in scores over this time point.
    Time Frame
    6 weeks
    Title
    Fatigue Impact Scores. This validated questionaire will be self-completed at baseline and at week 6. The investigators will compare the changes in scores over this time point.
    Time Frame
    6 weeks
    Title
    Short-form 36 Quality of Life Scores. This validated questionaire will be self-completed at baseline and at week 6. The investigators will compare the changes in scores over this time point.
    Time Frame
    6 weeks
    Title
    Assess whether patients opt to continue with a GFD of their own volition
    Description
    At the end of the six-week GFD trial period, patients will be asked whether or not they plan to continue with a GFD of their own volition. This will be assessed by a "yes/no" answer. Those who choose to do so will now be followed-up under routine clinical care over the next 1-2 years. This will allow the investigators to assess whether symptom-remission is maintained by using the same questionnaires mentioned in outcomes 1 to 4. It will also allow the investigators to monitor well-being in the form of body-mass index and serum haematinics (vitamin B12, folate, ferritin, albumin, haemoglobin).
    Time Frame
    1-2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aged 16 years or over Patients fulfilling ROME III symptom based criteria for IBS-D but do not have coeliac disease Exclusion Criteria: Patients diagnosed with coeliac disease Patients already on a gluten-free diet Patients initially referred with self-reported gluten sensitivity Patients with organic conditions that can mimic IBS-D such as idiopathic bile acid diarrhoea, pancreatic insufficiency, microscopic colitis, and inflammatory bowel disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Sanders
    Organizational Affiliation
    Sheffield Teaching Hospitals NHS Foundation Trust
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26748221
    Citation
    Aziz I, Trott N, Briggs R, North JR, Hadjivassiliou M, Sanders DS. Efficacy of a Gluten-Free Diet in Subjects With Irritable Bowel Syndrome-Diarrhea Unaware of Their HLA-DQ2/8 Genotype. Clin Gastroenterol Hepatol. 2016 May;14(5):696-703.e1. doi: 10.1016/j.cgh.2015.12.031. Epub 2015 Dec 31.
    Results Reference
    derived

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