Functional dyspepsia, heartburn Functionele dyspepsie, zuurbranden
Conditions
Interventions
All patients will receive in one period either a placebo or Iberogast (STW5) (20 drops three times daily) for at least 4 weeks, followed by a second period in which they will receive the other study m
Sponsors
Academisch Medisch Centrum Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: - Age above 18 - A history of dyspepsia (according to the Rome IV criteria) with heartburn - Upper gastro-intestinal causes of the complaints excluded via gastroscopy with in addition an abdominal echography if found to be necessary by the physician
Exclusion criteria
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 …) - Proton pump inhibitors cannot be stopped for 7 days before start of the study - Known Barrett's oesophagus - History of GI cancer - Known allergy to one of the ingredients of Iberogast - Known diabetes - Severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders) - Pregnancy (women will be asked if they are pregnant)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Gastro-oesophageal reflux disease symptom score improvement based on RDQ Questionnaire score | — |
Secondary
| Measure | Time frame |
|---|---|
| - Number of gastro-oesophageal reflux episodes during the 24-hr study (both mixed/liquid reflux episodes and both acidic and non-acidic episodes) - Proportion of acid and non-acid reflux episodes - Total acid exposure time during 24-hour pH-impedance studies - Quality of life (using the Quality of life in Reflux and Dyspepsia QoLRaD Questionnaire) - Oesophageal sensitivity to acid perfusion Time to symptoms during oesophageal acid exposure Time to pain during oesophageal acid exposure (if present) Symptom severity during oesophageal acid exposure (VAS) | — |
Contacts
Public ContactA.J. Bredenoord
Meibergdreef 9
Outcome results
None listed