FODMAPs and Refractory GERD

Not Applicable

Completed

• Conditions: Gastro-esophageal Reflux Disease (GERD)
• Interventions: Dietary Supplement: GERD diet; Dietary Supplement: Low-FODMAP diet

• Registration Number: NCT02471989
• Lead Sponsor: University Hospital, Bordeaux

Brief 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.

Study Timeline

• Study First Submitted: 2015-06-05
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-15
• Study Start: 2016-01-05
• Primary Completion: 2018-11-13
• Study Completion: 2018-11-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Classical GERD diet	GERD diet	avoid fatty meals, head of bed elevation...
Low-FODMAP diet	Low-FODMAP diet	FOS in diet

Primary Outcome Measures

Name	Time	Method
Percentage of patients with clinical remission as defined by a RDQ score ≤ 3	at Week 4 of diet

Secondary Outcome Measures

Name	Time	Method
Between-group comparison of efficacy	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

Trial Locations

Locations (4)

Explorations fonctionnelles; 🇫🇷 Lyon, France

Explorations fonctionnelles Digestives; 🇫🇷 Rennes, France

Gastroentérologie; 🇫🇷 Rouen, France

Hépato-Gastroentérologie et oncologie digestive,; 🇫🇷 Bordeaux, France