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

NCT03492333 | Completed

• 1 other identifier: AGA_GFD_in_IBS
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

IBS - Irritable Bowel Syndrome

Keywords

antigliadin, gluten free diet, transit

Outcome Measures

Primary Outcomes (1)

• Improvement on gastrointestinal symptoms

  Decrease \>2 points IBS Birmingham score

  4 weeks

Secondary Outcomes (5)

• Normalization of gastrointestinal transit

  4 weeks

• Improvement anxiety and/or depression

  4 weeks

• Improvement somatization

  4 weeks

• Improvement quality of life and well-being

  4 weeks

• Changes in gut microbiota

  4 weeks

Study Arms (1)

Gluten free diet

EXPERIMENTAL

Single arm

Other: Gluten free diet

Interventions

Gluten free diet OTHER

Gluten-free diet- Instructions provided by a dietitian

Gluten free diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients
• IBS diagnosis (Rome III)
• Willingness to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Farncombe Institute

Hamilton, Ontario, L8S4K1, Canada

Location

Related Publications (1)

• 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.

  PMID: 32827724 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Premysl Bercik, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention GFD in IBS and HV(controls)

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 10, 2018
• Study Start: April 30, 2012
• Primary Completion: May 30, 2016
• Study Completion: May 30, 2016
• Last Updated: April 10, 2018

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)