FODMAPs and Refractory GERD

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02471989

Acronym

EFFORR

Enrollment

Registered

2015-06-15

Start date

2016-01-05

Completion date

2018-11-13

Last updated

2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-esophageal Reflux Disease (GERD)

Keywords

FODMAP, Diet, pH-impedance monitoring

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.

Interventions

DIETARY_SUPPLEMENTLow-FODMAP diet

DIETARY_SUPPLEMENTGERD diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORFrank ZERBIB, Prof

University Hospital, Bordeaux

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026