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

IBS - Irritable Bowel Syndrome Clinical Trial

— GFD_IBS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492333
• Other study ID #: AGA_GFD_in_IBS
• Status: Completed
• Phase: N/A
• First received: April 3, 2018
• Last updated: April 3, 2018
• Start date: April 30, 2012
• Est. completion date: May 30, 2016

Study information

• Verified date: July 2017
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 30, 2016
• Est. primary completion date: May 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• IBS - Irritable Bowel Syndrome
• Irritable Bowel Syndrome

Intervention

Other:
• Gluten free diet
Gluten-free diet- Instructions provided by a dietitian

Locations

Country	Name	City	State
Canada	Farncombe Institute	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement on gastrointestinal symptoms	Decrease >2 points IBS Birmingham score	4 weeks
Secondary	Normalization of gastrointestinal transit	(SHAPE 25-50 radiopaque markers)	4 weeks
Secondary	Improvement anxiety and/or depression	Decrease >2 points Hospital anxiety and depression (HAD) score	4 weeks
Secondary	Improvement somatization	Decrease somatization scores (PHQ15)	4 weeks
Secondary	Improvement quality of life and well-being	Decrease in the psychological general well-being (PGWB) score	4 weeks
Secondary	Changes in gut microbiota	changes in microbial composition	4 weeks