FODMAPs and Refractory GERD (EFFORR)

University Hospital of Bordeaux

Status: Unknown

Conditions: Gastro-esophageal Reflux Disease (GERD)

Treatments: Dietary Supplement: GERD diet; Dietary Supplement: Low-FODMAP diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02471989

CHUBX 2015/02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

60 participants in 2 patient groups

Low-FODMAP diet

Experimental group

Description:

FOS in diet

Treatment:

Dietary Supplement: Low-FODMAP diet

Classical GERD diet

Active Comparator group

Description:

avoid fatty meals, head of bed elevation...

Treatment:

Dietary Supplement: GERD diet