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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-FODMAP diet | Experimental | FOS in diet |
|
| Classical GERD diet | Active Comparator | avoid fatty meals, head of bed elevation... |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-FODMAP diet | Dietary Supplement |
| ||
| GERD diet |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with clinical remission as defined by a RDQ score ≤ 3 | at Week 4 of diet |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group comparison of efficacy | This measure is a composite with :
| at Week 4 of diet |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank ZERBIB, Prof | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hépato-Gastroentérologie et oncologie digestive, | Bordeaux | 33075 | France | |||
| Gastroentérologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34051134 | Result | 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. |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000092622 | FODMAP Diet |
| ID | Term |
|---|---|
| D000092724 | Elimination Diets |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
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|
| Colombes |
| 92700 |
| France |
| Explorations fonctionnelles | Lyon | 69437 | France |
| Gastroentérologie | Nantes | 44093 | France |
| Explorations fonctionnelles Digestives | Rennes | 35033 | France |
| Gastroentérologie | Rouen | 76031 | France |
| D004066 | Digestive System Diseases |
| D010829 | Physiological Phenomena |