A Low FODMAPs Diet in Celiac Patients With Persistent Gastrointestinal Symptoms

October 26, 2016 updated by: Leda Roncoroni, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

The Efficacy of a Low FODMAPs (Fermentable Oligo- di- and Monosaccharides and Polyols) Diet in Celiac Patients With Persistent Gastrointestinal Symptoms

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20122
        • Recruiting
        • University of Milan
        • Contact:
        • Sub-Investigator:
          • Luca Elli, MD PhD
        • Sub-Investigator:
          • Vincenza Lombardo, BS
        • Sub-Investigator:
          • Zaira Tuccitto, BS student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Celiac patients assessed through positive serology and histology
  • functional patients according IBS Roma III criteria
  • subjects with VAS>5

Exclusion Criteria:

  • refractory celiac disease
  • disaccharide intolerance (fructose an lactose breath test)
  • abdominal surgery
  • comorbidity
  • patients recruited in other clinical trials
  • positive patients at lactulose breath test (SIBO)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low FODMAPs /balanced gluten free diet
An expert in nutrition will give a balanced gluten free diet to patients, low in FODMAPs foods.
Dietary supplement: Balanced low FODMAPs /gluten free diet
Active Comparator: Balanced gluten free diet
An expert in nutrition will give a balanced gluten free diet to patients.
Dietary supplement: Balanced gluten free diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of VAS (psychometric response scale level continuous line between two end-points 0-10) values of globel well-being in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients in balanced gluten free diet.
Time Frame: 21 days
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of VAS values of IBS symptoms in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet.
Time Frame: 21 days
Evaluated IBS symptoms are: abdominal pain, bloating, satisfaction with stool consistency, epigastric pain, postprandial fullness, early satiety.
21 days
Improvement of quality of life assessed through SF-36 questionnaire (eight scale scores) in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet.
Time Frame: 21 days
21 days
Improvement of psychological problems and symptoms of psychopathology through the symptom checklist 90 R (SCL 90 R) in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet.
Time Frame: 21 days
21 days
Evaluation of the dietary intake in micro and macro-nutrients before and after a Low FODMAP diet or a balanced Gluten Free diet through questionnaire.
Time Frame: 21 days
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (Estimate)

October 27, 2016

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/464

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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