UZ Leuven
Leuven, 3000, Belgium
NCT Number: NCT03777787
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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Notify Me18 year–65 year
Female
Interventional
Not applicable
Leuven, 3000, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single intragastric administration of denatonium benzoate (1 µmol/kg)
A single intragastric administration of water
Time frame: 1 week
Changes in the number of transient lower esophageal sphincter relaxations (TLESRs) between the placebo and bitter condition.
Time frame: 1 week
The change in the number of reflux events between placebo and bitter condition.
Time frame: 1 week
The change in the intragastric pressure between placebo and bitter condition.
Time frame: 1 week
The change in motilin concentration between placebo and bitter condition.
Time frame: 1 week
Change in the number of volunteers reporting gastrointestinal symptoms between placebo and bitter condition
Universitaire Ziekenhuizen KU Leuven
Other
The Relationship Between Acute Administration of a Bitter Compound and Transient Lower Esophageal Sphincter Relaxations and Reflux Events in Healthy Subjects
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