FODMAPs and Refractory GERD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-05

Study Completion Date

2018-11-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastro-esophageal Reflux Disease (GERD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Low-FODMAP diet

FOS in diet

Group Type EXPERIMENTAL

Low-FODMAP diet

Intervention Type DIETARY_SUPPLEMENT

Classical GERD diet

avoid fatty meals, head of bed elevation...

Group Type ACTIVE_COMPARATOR

GERD diet

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Low-FODMAP diet

Intervention Type DIETARY_SUPPLEMENT

GERD diet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No