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Completed

NCT Number: NCT02471989

FODMAPs and Refractory GERD

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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Key information

Conditions

Gastro-esophageal Reflux Disease (GERD) Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hépato-Gastroentérologie et oncologie digestive,, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Low-FODMAP diet

Dietary Supplement

GERD diet

Dietary Supplement

Primary outcomes

  1. Percentage of patients with clinical remission as defined by a RDQ score ≤ 3

    Time frame: at Week 4 of diet

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: EFFORR

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2015
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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