Benesco TM for reflux symptoms
- Conditions
- <p>Reflux</p>10017977
- Registration Number
- NL-OMON27122
- Lead Sponsor
- Amsterdam UMC, location AMC
- Brief Summary
One hundred participants were randomized. Treatment success was seen in 18 (39%) of 46 participants in the intervention group versus 21 (47%) of 45 in the placebo group (p = 0.468). In the intervention group 10 (1–21) reflux-free days were reported compared to 10 (2–25) in the placebo group (p = 0.673). In addition, 38 (34–41) versus 39 (35–42) reflux-free nights were reported (p = 0.409).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 108
In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Written informed consent. - Both male and female patients will be included. - 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).
A potential subject who meets any of the following criteria will be excluded from participation in this study: - 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 main objective of the study is to investigate if benescoTM reduces symptoms (study part A), esophageal acid sensitivity and permeability (study part B) in patients with reflux symptoms.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Reduction in symptom frequency and symptom severity (using a symptom diary). (A) To evaluate whether benescoTM results in improvement of the esophageal barrier function.(B)</p><br>