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Gluten Free Diet in IBS Patients Stratified According to Their Antigliadin Status

The Role of Antigliadin Antibodies in Predicting the Beneficial Effect of Gluten Free Diet in Unselected IBS Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03492333
Acronym
GFD_IBS
Enrollment
75
Registered
2018-04-10
Start date
2012-04-30
Completion date
2016-05-30
Last updated
2018-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBS - Irritable Bowel Syndrome

Keywords

antigliadin, gluten free diet, transit

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

Interventions

OTHERGluten free diet

Gluten-free diet- Instructions provided by a dietitian

Sponsors

McMaster University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Intervention GFD in IBS and HV(controls)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement on gastrointestinal symptoms4 weeksDecrease \>2 points IBS Birmingham score

Secondary

MeasureTime frameDescription
Normalization of gastrointestinal transit4 weeks(SHAPE 25-50 radiopaque markers)
Improvement anxiety and/or depression4 weeksDecrease \>2 points Hospital anxiety and depression (HAD) score
Improvement somatization4 weeksDecrease somatization scores (PHQ15)
Improvement quality of life and well-being4 weeksDecrease in the psychological general well-being (PGWB) score
Changes in gut microbiota4 weekschanges in microbial composition

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026