Gluten Free Diet in IBS Patients Stratified According to Their Antigliadin Status (GFD_IBS)
Primary Purpose
IBS - Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Gluten free diet
Sponsored by
About this trial
This is an interventional diagnostic trial for IBS - Irritable Bowel Syndrome focused on measuring antigliadin, gluten free diet, transit
Eligibility Criteria
Inclusion Criteria:
- Adult patients
- IBS diagnosis (Rome III)
- Willingness to participate
Exclusion Criteria:
- history of any organic disease including celiac disease
- Immune deficiency
- Major abdominal surgery
- Use of immunosuppressants, glucocorticosteroids or opioids
- Use of antibiotics in the last 3 months
Sites / Locations
- Farncombe Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gluten free diet
Arm Description
Single arm
Outcomes
Primary Outcome Measures
Improvement on gastrointestinal symptoms
Decrease >2 points IBS Birmingham score
Secondary Outcome Measures
Normalization of gastrointestinal transit
(SHAPE 25-50 radiopaque markers)
Improvement anxiety and/or depression
Decrease >2 points Hospital anxiety and depression (HAD) score
Improvement somatization
Decrease somatization scores (PHQ15)
Improvement quality of life and well-being
Decrease in the psychological general well-being (PGWB) score
Changes in gut microbiota
changes in microbial composition
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03492333
Brief Title
Gluten Free Diet in IBS Patients Stratified According to Their Antigliadin Status
Acronym
GFD_IBS
Official Title
The Role of Antigliadin Antibodies in Predicting the Beneficial Effect of Gluten Free Diet in Unselected IBS Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 30, 2012 (Actual)
Primary Completion Date
May 30, 2016 (Actual)
Study Completion Date
May 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Gluten-free diet has been shown to improve gut symptoms in patients with celiac disease and also in adult patients with diagnosis of Irritable Bowel Syndrome (Rome III criteria).
Antibodies to native gliadin (AGA) have been suggested as a potential diagnostic marker of response to GFD. However, this has not been tested in a prospective study in IBS patients. Identification of predictors of a symptomatic response to GFD within the IBS population would improve the clinical management of these patients.
The purpose of this study is to evaluate the effect of gluten-free diet on gastrointestinal symptoms and gut motility in patients with Irritable Bowel Syndrome stratified according to their antigliadin antibodies status.
Additional purposes include investigating effects gluten free diet may have on other parameters:
Improvement of mood
Quality of life and general well-being
Changes in gut microbiota
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome
Keywords
antigliadin, gluten free diet, transit
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intervention GFD in IBS and HV(controls)
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gluten free diet
Arm Type
Experimental
Arm Description
Single arm
Intervention Type
Other
Intervention Name(s)
Gluten free diet
Intervention Description
Gluten-free diet- Instructions provided by a dietitian
Primary Outcome Measure Information:
Title
Improvement on gastrointestinal symptoms
Description
Decrease >2 points IBS Birmingham score
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Normalization of gastrointestinal transit
Description
(SHAPE 25-50 radiopaque markers)
Time Frame
4 weeks
Title
Improvement anxiety and/or depression
Description
Decrease >2 points Hospital anxiety and depression (HAD) score
Time Frame
4 weeks
Title
Improvement somatization
Description
Decrease somatization scores (PHQ15)
Time Frame
4 weeks
Title
Improvement quality of life and well-being
Description
Decrease in the psychological general well-being (PGWB) score
Time Frame
4 weeks
Title
Changes in gut microbiota
Description
changes in microbial composition
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult patients
IBS diagnosis (Rome III)
Willingness to participate
Exclusion Criteria:
history of any organic disease including celiac disease
Immune deficiency
Major abdominal surgery
Use of immunosuppressants, glucocorticosteroids or opioids
Use of antibiotics in the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Premysl Bercik, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Farncombe Institute
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S4K1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data.
Citations:
PubMed Identifier
32827724
Citation
Pinto-Sanchez MI, Nardelli A, Borojevic R, De Palma G, Calo NC, McCarville J, Caminero A, Basra D, Mordhorst A, Ignatova E, Hansen S, Uhde M, Norman GL, Murray JA, Smecuol E, Armstrong D, Bai JC, Schuppan D, Collins SM, Alaedini A, Moayyedi P, Verdu EF, Bercik P. Gluten-Free Diet Reduces Symptoms, Particularly Diarrhea, in Patients With Irritable Bowel Syndrome and Antigliadin IgG. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2343-2352.e8. doi: 10.1016/j.cgh.2020.08.040. Epub 2020 Aug 19.
Results Reference
derived
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Gluten Free Diet in IBS Patients Stratified According to Their Antigliadin Status
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