to assess the effect of benescoTM on reflux symptoms (part A) and to evaluate the effect of benescoTM on esophageal sensitivity to acid and mucosal barrier function in subjects with reflux symptoms (part B).
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is treatment success, defined as a reduction in symptoms of
50%.
Secondary outcome
Secondary outcomes include reduction in symptom frequency and symptom severity
(using a symptom diary).
Background summary
Gastroesophageal reflux disease (GERD) is one of the most common
gastro-intestinal disorders with an estimated prevalence of 7%-33% worldwide.
Although proton pump inhibitor (PPI) therapy forms the mainstay of GERD
management, approximately one-third of the patients experience persistent
symptoms despite daily PPI use. Moreover, a subset of patients does not want to
use PPI and seeks for alternative therapies because of assumed side-effects
such as dementia, osteoporosis and pneumonia. Given the high prevalence of
GERD, reflux symptoms represent a significant clinical problem and press a high
burden on current health care. Esophageal mucosal barrier function, as the
underlying cause of esophageal hypersensitivity, is considered a potential
therapeutic target in reflux disease. benescoTM is an over-the-counter
nutritional supplement containing quercetin, a naturally-occurring flavonoid
that has a long history of consumption as part of the normal human diet.
Previous studies demonstrated that oral quercetin supports esophageal barrier
function and acid resistance. However to date, the clinical efficacy on reflux
symptoms and the effect on acid sensitivity in humans has not been studied yet.
If we are able to demonstrate the clinical effect of benescoTM for reduction of
reflux symptoms and confirm its role in supporting esophageal barrier function
and acid perception in humans, it will support the use of benescoTM as a
valuable natural alternative to PPI-treatment.
Study objective
to assess the effect of benescoTM on reflux symptoms (part A) and to evaluate
the effect of benescoTM on esophageal sensitivity to acid and mucosal barrier
function in subjects with reflux symptoms (part B).
Study design
A single centre, double-blind placebo-controlled randomized trial
Intervention
During the study period of 6 weeks, patients will receive 3 times daily 200 mg
of benescoTM or a placebo Patients will fill out symptom questionnaires at
baseline and every week for the total duration of the study (6 weeks) Moreover,
patients will report a daily symptom diary (part A). Eight reflux patients are
asked to participate in the mechanistic intervention study (study part B).
These subjects will undergo additional testing at baseline and after 6 weeks of
treatment by means of upper endoscopy with biopsy sampling, electrical tissue
impedance spectroscopy and an acid perfusion test
Study burden and risks
For the treatment period of six weeks, subjects will fill out short symptom
diaries and weekly symptom questionnaires (on six separate occasions). There
will be one study visit, which can be either a physical visit to the hospital
or a video conference call. benescoTM is an over-the-counter nutritional
supplement containing quercetin. Numerous clinical studies have proven good
safety of quercetin and no compound-related adverse effects or evidence for
toxicity have been found. The subgroup of subjects that will participate in the
part B study, will undergo two upper endoscopies with biopsy sampling and two
esophageal acid perfusion tests. Both endoscopy and acid perfusion test cause
mild discomfort. Sedation can be provided on demand. Risk of perforation or
bleeding of biopsy taking is smaller than 1/10000 endoscopies. Participants
will be compensated financially for participation in the study and the findings
could help treat future patients with similar complaints.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL75630.018.20 |