Benesco for reflux symptoms: efficacy and mechanism of actio

Completed

• Conditions: Hearburn; pyrosis; 10017977

• Registration Number: NL-OMON54012
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 108

Inclusion Criteria

- Age above 18 years.
- Symptoms of heartburn and/or acid regurgitation at least 3 times a week
- A total reflux symptom score >=8 (measured through the GerdQ questionnaire
score).

Exclusion Criteria

- Use of any medication with an effect on gastrointestinal motility, secretion
or sensitivity that cannot be stopped for the duration of the study except
antacids (e.g. proton pump inhibitors, H2-blockers, antidepressants,
prokinetics). Medication must be stopped at least two weeks upon inclusion.
- Less than 50% response to PPI (if previously used)
- Known Barrett*s esophagus
- History of gastric or esophageal surgery
- Known allergy to one of the ingredients of Benesco
- Severe and clinically unstable concomitant disease (e.g. liver,
cardiovascular or lung disease, neurological or psychiatric disorders, cancer
or AIDS and other endocrine disorders)
- Pregnant, lactating or fertile women (without contraception)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is treatment success, defined as a reduction in symptoms of<br /><br>50%. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include reduction in symptom frequency and symptom severity<br /><br>(using a symptom diary). </p><br>