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Bitter Tastants and Reflux

Primary Purpose

Gastro Esophageal Reflux

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Denatonium Benzoate
Water
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gastro Esophageal Reflux focused on measuring Bitter, TLESRs, Gastric tone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy female volunteers
  • Age between 18 and 65
  • Written informed consent

Exclusion Criteria:

  • A history of any upper GI symptoms or GI surgery;
  • Psychological disorders;
  • Concomitant use of other medication or treatments except for oral contraceptives;
  • Use of medication altering esophageal or GI motility;
  • Pregnant or nursing women.

Sites / Locations

  • UZ Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bitter

Placebo

Arm Description

A single intragastric administration of denatonium benzoate (1 µmol/kg)

A single intragastric administration of placebo (water)

Outcomes

Primary Outcome Measures

Change in number of TLESRs
Changes in the number of transient lower esophageal sphincter relaxations (TLESRs) between the placebo and bitter condition.

Secondary Outcome Measures

Change in reflux
The change in the number of reflux events between placebo and bitter condition.
Change in motility pattern
The change in the intragastric pressure between placebo and bitter condition.
Change in motilin concentration
The change in motilin concentration between placebo and bitter condition.
Change in symptoms
Change in the number of volunteers reporting gastrointestinal symptoms between placebo and bitter condition

Full Information

First Posted
December 11, 2018
Last Updated
June 5, 2019
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT03777787
Brief Title
Bitter Tastants and Reflux
Official Title
The Relationship Between Acute Administration of a Bitter Compound and Transient Lower Esophageal Sphincter Relaxations and Reflux Events in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
May 10, 2019 (Actual)
Study Completion Date
May 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro Esophageal Reflux
Keywords
Bitter, TLESRs, Gastric tone

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, double-blind, placebo-controlled study
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bitter
Arm Type
Experimental
Arm Description
A single intragastric administration of denatonium benzoate (1 µmol/kg)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A single intragastric administration of placebo (water)
Intervention Type
Dietary Supplement
Intervention Name(s)
Denatonium Benzoate
Intervention Description
A single intragastric administration of denatonium benzoate (1 µmol/kg)
Intervention Type
Dietary Supplement
Intervention Name(s)
Water
Intervention Description
A single intragastric administration of water
Primary Outcome Measure Information:
Title
Change in number of TLESRs
Description
Changes in the number of transient lower esophageal sphincter relaxations (TLESRs) between the placebo and bitter condition.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Change in reflux
Description
The change in the number of reflux events between placebo and bitter condition.
Time Frame
1 week
Title
Change in motility pattern
Description
The change in the intragastric pressure between placebo and bitter condition.
Time Frame
1 week
Title
Change in motilin concentration
Description
The change in motilin concentration between placebo and bitter condition.
Time Frame
1 week
Title
Change in symptoms
Description
Change in the number of volunteers reporting gastrointestinal symptoms between placebo and bitter condition
Time Frame
1 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy female volunteers Age between 18 and 65 Written informed consent Exclusion Criteria: A history of any upper GI symptoms or GI surgery; Psychological disorders; Concomitant use of other medication or treatments except for oral contraceptives; Use of medication altering esophageal or GI motility; Pregnant or nursing women.
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

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Bitter Tastants and Reflux

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