FODMAPs and Refractory GERD (EFFORR)

December 17, 2015 updated by: University Hospital, Bordeaux

Randomized Controlled Study of Low-FODMAP Diet in Patients With GERD Refractory to Protons Pump Inhibitors

The aim of this study is to determine the effects of a low Fermentescible Oligosaccharides Disaccharides Monosaccharides and Polyols (FODMAP) diet in patients with documented refractory GERD on proton pump inhibitor (PPI) therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Colonic fermentation has been shown to influence oeso-gastric motility : increased gastric relaxation, increased rate of lower esophageal sphincter relaxation. Experimental increased colonic fermentation (FOS in diet) increase the occurrence of reflux events in patients with GERD. The aim of this study is to compare the low-FODMAP diet and classical GERD dietary recommendations (avoid fatty meals, head of bed elevation etc..) in patients with refractory GERD symptoms.

Study Type

Interventional

Enrollment (Anticipated)

60

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

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18
  • Affiliation to French Social Security
  • Informed written consent
  • RDQ score > 3
  • Abnormal pH-impedance monitoring on PPI twice daily (since 3 months) according to normal values published by Zerbib et al (CGH 2013)

Exclusion Criteria:

  • Pregnancy or breast feeding
  • Women of childbearing potential without an effective method of contraception
  • Person under guardianship
  • History of thoracic of abdominal surgery (excepted appendectomy and cholecystectomy)

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-FODMAP diet
FOS in diet
Dietary supplement: Low-FODMAP diet
Active Comparator: Classical GERD diet
avoid fatty meals, head of bed elevation...
Dietary supplement: GERD diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with clinical remission as defined by a RDQ score ≤ 3
Time Frame: at Week 4 of diet
at Week 4 of diet

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Between-group comparison of efficacy
Time Frame: at Week 4 of diet

This measure is a composite with :

  • Reflux Disease Questionnaire (RDQ) scores
  • Francis Irritable Bowel Syndrome (IBS) score
  • Quality of life (GIQLI) score
  • and reflux parameter on pH-impedance monitoring
at Week 4 of diet

Collaborators and Investigators

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

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Frank ZERBIB, Prof, University Hospital, Bordeaux

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

November 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

June 5, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 15, 2015

Study Record Updates

Last Update Posted (Estimate)

December 18, 2015

Last Update Submitted That Met QC Criteria

December 17, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2015/02

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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