FODMAPs and Refractory GERD (EFFORR)

U

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

Trial contacts and locations

0

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Central trial contact

Amandine MOURTHE; Frank ZERBIB, Prof

Data sourced from clinicaltrials.gov

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