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FODMAPs and Refractory GERD | Clinical Trials | Clareo Health

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FODMAPs and Refractory GERD

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

NCT02471989•University Hospital, Bordeaux

Summary

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)

Locations (6)

Hépato-Gastroentérologie et oncologie digestive,

Bordeaux, France

Gastroentérologie

Colombes, France

Explorations fonctionnelles

Lyon, France

Gastroentérologie

Nantes, France

Explorations fonctionnelles Digestives

Rennes, France

Gastroentérologie

Rouen, France

Key Dates

Start Date

January 5, 2016

Primary Completion Date

November 13, 2018

Completion Date

November 13, 2018

Last Updated

August 12, 2024

Enrollment

ACTUAL participants

Conditions

Gastro-esophageal Reflux Disease (GERD)

Interventions

Low-FODMAP diet

DIETARY_SUPPLEMENT

GERD diet

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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