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Gluten-free Diet in Irritable Bowel Syndrome

NHS Foundation Trust logo

NHS Foundation Trust

Status

Completed

Conditions

Irritable Bowel Syndrome

Treatments

Dietary Supplement: Gluten-free diet

Study type

Interventional

Funder types

Other

Identifiers

NCT02528929
STH16497

Details and patient eligibility

About

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

Full description

Irritable bowel syndrome with diarrhoea (IBS-D) is commonly encountered in primary and secondary-care practice. There are various triggers including diet. There is a growing number of people taking a gluten-free diet (GFD) of their own volition even in the absence of coeliac disease (CD). The investigators aim to assess whether a GFD could be of benefit to patients with IBS-D, previously naive to the effects of gluten and in whom CD has been excluded as per normal duodenal biopsies. The investigators will also assess whether certain factors may predict a clinical responder such as the presence or absence of at-risk coeliac serology.

Enrollment

48 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 2 patient groups

At-risk serology
Active Comparator group
Description:
Gluten-free diet
Treatment:
Dietary Supplement: Gluten-free diet
Not at-risk serology
Active Comparator group
Description:
Gluten-free diet
Treatment:
Dietary Supplement: Gluten-free diet

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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