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A Low FODMAPs Diet in Celiac Patients With Persistent Gastrointestinal Symptoms

NCT02946827 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2016-10-27

No results posted yet for this study

Summary

FODMAPS (fructose, oligosaccharides, monosaccharides, disaccharides and polyols) are characterised as fermentable but poorly absorbed carbohydrates which enter the colon and are utilised by colonic bacteria. During fasting colonic nutrients are scarce but ingesting FODMAPS causes a rapid increase in carbohydrate which can overwhelm the microbiota's ability to utilise substrate. The excess reducing equivalents will generate hydrogen or methane. The principal symptoms are diarrhoea and abdominal distension. Patients with irritable bowel syndrome appear to benefit by restricting intake, possibly because they are hypersensitive to intestinal distension.

The focus of the study is to evaluate if in celiac patients with persistent abdominal symptoms and with a correct gluten free diet, a low FODMAPs diet can improve their symptoms. Moreover the study would like to observe if a dietary restriction in FODMAPs carries the risk of nutritional inadequacy.

Conditions

Interventions

DIETARY_SUPPLEMENT

Balanced low FODMAPs /gluten free diet

DIETARY_SUPPLEMENT

Balanced gluten free diet

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-11-30
Completion
2017-01-31

Countries

  • Italy

Study Locations

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Entities

Diseases

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 NCT02946827 on ClinicalTrials.gov