MedTrace Logo

Identification of Gluten Sensitivity in Irritable Bowel Syndrome

NCT04017585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-12-27

No results posted yet for this study

Summary

The aim of our study will be to establish in how many subjects with gastrointestinal symptoms and previous diagnosis of irritable bowel syndrome (IBS), the clinical picture is attributable to non celiac gluten sensitivity (NCGS) or fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) intolerance. For this purpose, all subjects with IBS will take a low FODMAPs diet, which implies the absence of cereals and consequently of gluten, and those presenting symptom improvement during this dietary treatment, will be exposed to a double-blind gluten or placebo challenge, to make a diagnosis of NCGS.

Conditions

  • Non-celiac Gluten Sensitivity
  • Irritable Bowel Syndrome

Interventions

DIETARY_SUPPLEMENT

diet containing gluten

gluten will be added for 7 days to the low FODMAP/gluten free diet diet. After 1 week of wash-out, patients will switch (cross-over) to placebo for another 7 days

DIETARY_SUPPLEMENT

Diet containing placebo

Placebo will be added for 7 days to the low FODMAP/gluten free diet diet. After 1 week of wash-out, patients will switch (cross-over) to gluten for another 7 days

Sponsors & Collaborators

  • University of Bari

    lead OTHER

Principal Investigators

  • Michele Barone · University of Bari

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-08
Primary Completion
2019-09-30
Completion
2019-10-30

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04017585 on ClinicalTrials.gov