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NCT Number: NCT03492333

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

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

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Key information

Conditions

IBS - Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Farncombe Institute

Hamilton, Ontario, L8S4K1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gluten free diet

Other

Gluten-free diet- Instructions provided by a dietitian

Primary outcomes

  1. Improvement on gastrointestinal symptoms

    Time frame: 4 weeks

    Decrease >2 points IBS Birmingham score

Secondary outcomes

  1. Normalization of gastrointestinal transit

    Time frame: 4 weeks

    (SHAPE 25-50 radiopaque markers)

  2. Improvement anxiety and/or depression

    Time frame: 4 weeks

    Decrease >2 points Hospital anxiety and depression (HAD) score

  3. Improvement somatization

    Time frame: 4 weeks

    Decrease somatization scores (PHQ15)

  4. Improvement quality of life and well-being

    Time frame: 4 weeks

    Decrease in the psychological general well-being (PGWB) score

  5. Changes in gut microbiota

    Time frame: 4 weeks

    changes in microbial composition

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Acronym: GFD_IBS

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 10, 2018
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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