NCT02528929

Brief Summary

To evaluate the effects of a gluten-free diet in irritable bowel syndrome.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2018

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

5.9 years

First QC Date

August 18, 2015

Last Update Submit

April 2, 2019

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Irritable Bowel Syndrome Symptom Severity Scores. This validated questionaire will be self-completed at baseline and at week 6. The investigators will compare the changes in scores over this time point.

    6 weeks

Secondary Outcomes (4)

  • Hospital Anxiety and Depression scores. This validated questionaire will be self-completed at baseline and at week 6. The investigators will compare the changes in scores over this time point.

    6 weeks

  • Fatigue Impact Scores. This validated questionaire will be self-completed at baseline and at week 6. The investigators will compare the changes in scores over this time point.

    6 weeks

  • Short-form 36 Quality of Life Scores. This validated questionaire will be self-completed at baseline and at week 6. The investigators will compare the changes in scores over this time point.

    6 weeks

  • Assess whether patients opt to continue with a GFD of their own volition

    1-2 years

Study Arms (2)

At-risk serology

ACTIVE COMPARATOR

Gluten-free diet

Dietary Supplement: Gluten-free diet

Not at-risk serology

ACTIVE COMPARATOR

Gluten-free diet

Dietary Supplement: Gluten-free diet

Interventions

Gluten-free dietDIETARY_SUPPLEMENT

Patients with IBS-D will commence a gluten-free diet for 6 weeks following dietetic input. They will be informed they do not have coeliac disease. They will however be blinded to whether or not they have any markers of at-risk serology. They will self-complete validated questionnaires over 6 weeks. Any subjects who opt to continue with a gluten-free diet thereafter of their own volition will be kept under observation as per routine clinical care.

At-risk serologyNot at-risk serology

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 16 years or over
  • Patients fulfilling ROME III symptom based criteria for IBS-D but do not have coeliac disease

You may not qualify if:

  • Patients diagnosed with coeliac disease
  • Patients already on a gluten-free diet
  • Patients initially referred with self-reported gluten sensitivity
  • Patients with organic conditions that can mimic IBS-D such as idiopathic bile acid diarrhoea, pancreatic insufficiency, microscopic colitis, and inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Aziz I, Trott N, Briggs R, North JR, Hadjivassiliou M, Sanders DS. Efficacy of a Gluten-Free Diet in Subjects With Irritable Bowel Syndrome-Diarrhea Unaware of Their HLA-DQ2/8 Genotype. Clin Gastroenterol Hepatol. 2016 May;14(5):696-703.e1. doi: 10.1016/j.cgh.2015.12.031. Epub 2015 Dec 31.

    PMID: 26748221DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • David Sanders

    Sheffield Teaching Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2015

First Posted

August 19, 2015

Study Start

September 1, 2012

Primary Completion

July 31, 2018

Study Completion

November 13, 2018

Last Updated

April 4, 2019

Record last verified: 2019-04