Study to Learn More About the Stomach and Intestine Complaints of Children Aged From 3 to 14 Years

Completed

• Conditions: Functional Gastrointestinal Disorders

• Registration Number: NCT04029376
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-04-01
• Primary Completion: 2008-10-01
• Study Completion: 2008-10-01
• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-23
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1032

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global Assessment of the Efficacy by the Physicians	Up to 1 week	Treatment success assessed by physicians
Global Assessment of the Efficacy by the Children or Their Parents	Up to 1 week	Treatment success judged by children or their parents
Lost Attendance days	Up to 1 week	The number of lost attendance days kindergarten/school
Gastrointestinal Symptoms Profile (GIS) Score	Up to 1 week	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.

Secondary Outcome Measures

Name	Time	Method
The number of subjects with adverse events	Up to 1 week	The number of subjects who had any adverse event during the study
Global Assessment of the Tolerability by the Physician	Up to 1 week	The tolerability of Iberogast assessed by physician

Trial Locations

Locations (1)

Many locations; 🇩🇪 Multiple Locations, Germany