The effect of Iberogast on heartburn in patients with indigestio
- Conditions
- Functional dyspepsia, heartburnFunctionele dyspepsie, zuurbranden
- Registration Number
- NL-OMON28589
- Lead Sponsor
- Academisch Medisch Centrum Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
Age above 18
- A history of dyspepsia (according to the Rome IV criteria) with heartburn
Exclusion Criteria
- Surgery of the GI tract other than appendectomy or cholecystectomy
- Use of any medication with a potential effect on gastrointestinal motility, secretion or sensitivity that cannot be stopped for the duration of the study (e.g. proton pump inhibitors, H2-blockers, tricyclic antidepressants …)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Gastro-oesophageal reflux disease symptom score improvement based on RDQ Questionnaire score
- Secondary Outcome Measures
Name Time Method - Number of gastro-oesophageal reflux episodes during the 24-hr study (both mixed/liquid reflux episodes and both acidic and non-acidic episodes)<br /><br>- Proportion of acid and non-acid reflux episodes<br /><br>- Total acid exposure time during 24-hour pH-impedance studies<br /><br>- Quality of life (using the Quality of life in Reflux and Dyspepsia QoLRaD Questionnaire)<br /><br>- Oesophageal sensitivity to acid perfusion<br /><br> Time to symptoms during oesophageal acid exposure<br /><br> Time to pain during oesophageal acid exposure (if present)<br /><br> Symptom severity during oesophageal acid exposure (VAS)