Gastro-esophageal Reflux Disease (GERD)EFFORRNCT02471989
FODMAPs and Refractory GERD
A study testing Low-FODMAP diet and GERD diet in people with Gastro-esophageal Reflux Disease (GERD), run by University Hospital, Bordeaux at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-esophageal Reflux Disease (GERD)
- What is being tested?
- Low-FODMAP diet and GERD diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 6 sitesFrance
- Study dates
- 5 Jan 2016to 13 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Hépato-Gastroentérologie et oncologie digestive,
Bordeaux, 33075
Gastroentérologie
Colombes, 92700
Explorations fonctionnelles
Lyon, 69437
Gastroentérologie
Nantes, 44093
Explorations fonctionnelles Digestives
Rennes, 35033
Gastroentérologie
Rouen, 76031
About this study
Official title: Randomized Controlled Study of Low-FODMAP Diet in Patients With GERD Refractory to Protons Pump Inhibitors
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.
Read the 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.
- Conditions
- Gastro-esophageal Reflux Disease (GERD)
- Being tested
- Low-FODMAP diet, GERD diet
- Keywords
- FODMAP, Diet, pH-impedance monitoring
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-FODMAP dietDietary supplement
GERD dietDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Low-FODMAP diet | Experimental | FOS in diet Receives: Dietary Supplement: Low-FODMAP diet |
| Classical GERD diet | Active comparator | avoid fatty meals, head of bed elevation... Receives: Dietary Supplement: GERD diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with clinical remission as defined by a RDQ score ≤ 3
Measured: at Week 4 of diet
Secondary outcomes (1)
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
Measured: at Week 4 of diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study start5 Jan 2016
- Primary completion13 Nov 2018
- Study completion13 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastro-esophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank ZERBIB, Prof, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471989
- Sponsor's protocol ID
- CHUBX 2015/02
- Acronym
- EFFORR
- Status last verified
- Aug 2024
- First submitted
- 5 Jun 2015
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Riviere P, Vauquelin B, Rolland E, Melchior C, Roman S, Bruley des Varannes S, Mion F, Gourcerol G, Sacher-Huvelin S, Zerbib F. Low FODMAPs diet or usual dietary advice for the treatment of refractory gastroesophageal reflux disease: An open-labeled randomized trial. Neurogastroenterol Motil. 2021 Sep;33(9):e14181. doi: 10.1111/nmo.14181. Epub 2021 May 29.
PubMed 34051134
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Low-FODMAP Diet in Patients With GERD Refractory to Protons Pump Inhibitors
- ClinicalTrials.gov ID
- NCT02471989
- Acronym / sponsor ID
- EFFORR / CHUBX 2015/02
- Conditions
- Gastro-esophageal Reflux Disease (GERD)
- Keywords
- FODMAP, Diet, pH-impedance monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 5 Jan 2016 (actual)
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 13 Nov 2018 (actual)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-FODMAP diet | Experimental | Dietary Supplement: Low-FODMAP dietFOS in diet |
| Classical GERD diet | Active comparator | Dietary Supplement: GERD dietavoid fatty meals, head of bed elevation... |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-FODMAP diet | Dietary supplement | Low-FODMAP diet |
| GERD diet | Dietary supplement | Classical GERD diet |
Primary outcome
Percentage of patients with clinical remission as defined by a RDQ score ≤ 3
Time frame: at Week 4 of diet
1 secondary outcome
Between-group comparison of efficacy
Time frame: at Week 4 of diet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 34051134Riviere P, Vauquelin B, Rolland E, Melchior C, Roman S, Bruley des Varannes S, Mion F, Gourcerol G, Sacher-Huvelin S, Zerbib F. Low FODMAPs diet or usual dietary advice for the treatment of refractory gastroesophageal reflux disease: An open-labeled randomized trial. Neurogastroenterol Motil. 2021 Sep;33(9):e14181. doi: 10.1111/nmo.14181. Epub 2021 May 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank ZERBIB, Prof principal investigator
University Hospital, Bordeaux
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-FODMAP diet and GERD diet in people with Gastro-esophageal Reflux Disease (GERD), run by University Hospital, Bordeaux at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with clinical remission as defined by a RDQ score ≤ 3 (time frame: at Week 4 of diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02471989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.