In this observational study, researchers want to gain more information on children suffering from abnormal stomach and intestine function (based on the Rome criteria) and treated Iberogast. The Rome criteria have been developed by experts to support doctors to diagnose stomach and intestine disorders. This study will focus on children aged from 3 to 14 years in age treated by their doctor with the herbal drug Iberogast for their stomach and intestine complaints for one week. Researcher want to learn more about the efficacy of Iberogast by observing the changes of symptoms related to the stomach and intestine disorders. In addition information on the safety of the drug and how well the drug is tolerated by the patients will be collected.
Study Type
OBSERVATIONAL
Enrollment
1,032
The medication was applied 3 times 20 drops per day before or at meals with some liquid, ideally to one week insofar.
Many locations
Multiple Locations, Germany
Gastrointestinal Symptoms Profile (GIS) Score
The score was developed by Steigerwald Arzneimittelwerk GmbH in co-operation with a gastroenterological expert group and validated (Holtmann et al. 2004, Adam et al., 2005). It consists of 10 individual symptoms that were regarded as being typical for dyspepsia. They were evaluated based on a 5-stage Likert scale. The score was adapted to the special situation of children and adolescents with functional gastrointestinal disorders as part of the study concept. The change in the summary score during therapy serves as evaluation criterion for the efficacy of the therapeutic measure. The symptoms profile essentially involves all the symptoms of functional dyspepsia mentioned by the German Society for Gastrointestinal and Metabolic Diseases (DGVS) or international Rome criteria. Its usability was confirmed by the validation procedure.
Time frame: Up to 1 week
Global Assessment of the Efficacy by the Physicians
Treatment success assessed by physicians
Time frame: Up to 1 week
Global Assessment of the Efficacy by the Children or Their Parents
Treatment success judged by children or their parents
Time frame: Up to 1 week
Lost Attendance days
The number of lost attendance days kindergarten/school
Time frame: Up to 1 week
Global Assessment of the Tolerability by the Physician
The tolerability of Iberogast assessed by physician
Time frame: Up to 1 week
The number of subjects with adverse events
The number of subjects who had any adverse event during the study
Time frame: Up to 1 week
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