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Recently the relationship between intragastric pressure (IGP) and reflux events after a meal was investigated, both in gastro-esophageal reflux disease (GERD) patients and in healthy volunteers. Ingestion of a meal was accompanied by a drop in IGP. However, the magnitude of this drop varied and was inversely correlated with the number of transient lower esophageal sphincter relaxations (TLESRs) and the number of reflux events, both in patients and in healthy volunteers: a smaller meal-induced drop in IGP was associated with a higher rate of reflux events and vice versa. This finding suggests that a smaller meal-induced drop may act as a trigger for reflux. It has been demonstrated that bitter administration leads to a smaller meal-induced drop. Therefore, bitter can be a dietary trigger for TLESRs facilitating the occurrence of symptoms of GERD. To evaluate this hypothesis, the researchers will study the relationship between bitter and the occurrence of TLESRs and reflux events in healthy volunteers. Additionally, it has been demonstrated that administering bitter also influences the concentration of motilin. Therefore, the research team will also measure the concentration of motilin to investigate whether changes in motilin concentrations can influence the number of TLESRs, via a change in gastric tone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bitter | Experimental | A single intragastric administration of denatonium benzoate (1 µmol/kg) |
|
| Placebo | Placebo Comparator | A single intragastric administration of placebo (water) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denatonium Benzoate | Dietary Supplement | A single intragastric administration of denatonium benzoate (1 µmol/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of TLESRs | Changes in the number of transient lower esophageal sphincter relaxations (TLESRs) between the placebo and bitter condition. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in reflux | The change in the number of reflux events between placebo and bitter condition. | 1 week |
| Change in motility pattern | The change in the intragastric pressure between placebo and bitter condition. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | 3000 | Belgium |
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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 |
|---|---|
| C043414 | denatonium |
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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Randomized, double-blind, placebo-controlled study
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| Water | Dietary Supplement | A single intragastric administration of water |
|
| 1 week |
| Change in motilin concentration | The change in motilin concentration between placebo and bitter condition. | 1 week |
| Change in symptoms | Change in the number of volunteers reporting gastrointestinal symptoms between placebo and bitter condition | 1 week |
| D004066 | Digestive System Diseases |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |