NCT02471989

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

January 5, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2018

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

2.9 years

First QC Date

June 5, 2015

Last Update Submit

August 8, 2024

Conditions

Gastro-esophageal Reflux Disease (GERD)

Keywords

FODMAPDietpH-impedance monitoring

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with clinical remission as defined by a RDQ score ≤ 3

    at Week 4 of diet

Secondary Outcomes (1)

  • Between-group comparison of efficacy

    at Week 4 of diet

Study Arms (2)

Low-FODMAP diet

EXPERIMENTAL

FOS in diet

Dietary Supplement: Low-FODMAP diet

Classical GERD diet

ACTIVE COMPARATOR

avoid fatty meals, head of bed elevation...

Dietary Supplement: GERD diet

Interventions

Low-FODMAP dietDIETARY_SUPPLEMENT
Low-FODMAP diet
GERD dietDIETARY_SUPPLEMENT
Classical GERD diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hépato-Gastroentérologie et oncologie digestive,

Bordeaux, 33075, France

Location

Gastroentérologie

Colombes, 92700, France

Location

Explorations fonctionnelles

Lyon, 69437, France

Location

Gastroentérologie

Nantes, 44093, France

Location

Explorations fonctionnelles Digestives

Rennes, 35033, France

Location

Gastroentérologie

Rouen, 76031, France

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination DietsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Frank ZERBIB, Prof

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2015

First Posted

June 15, 2015

Study Start

January 5, 2016

Primary Completion

November 13, 2018

Study Completion

November 13, 2018

Last Updated

August 12, 2024

Record last verified: 2024-08

Locations

FR(6)