FODMAPs and Refractory GERD

Gastro-esophageal Reflux Disease (GERD) Clinical Trial

— EFFORR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02471989
• Other study ID #: CHUBX 2015/02
• Status: Recruiting
• Phase: N/A
• First received: June 5, 2015
• Last updated: December 17, 2015
• Start date: November 2015
• Est. completion date: December 2017

Study information

• Verified date: December 2015
• Source: University Hospital, Bordeaux
• Contact: Frank ZERBIB, Prof
• Phone: (0)556795806
• Email: frank.zerbib[@]chu-bordeaux.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Gastro-esophageal Reflux Disease (GERD)
• Gastroesophageal Reflux

Intervention

Dietary Supplement:
• Low-FODMAP diet

• GERD diet

Locations

Country	Name	City	State
France	Hépato-Gastroentérologie et oncologie digestive,	Bordeaux
France	Gastroentérologie	Colombes
France	Explorations fonctionnelles	Lyon
France	Gastroentérologie	Nantes
France	Explorations fonctionnelles Digestives	Rennes
France	Gastroentérologie	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with clinical remission as defined by a RDQ score = 3		at Week 4 of diet	No
Secondary	Between-group comparison of efficacy	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	No