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

Functional Gastrointestinal Disorders Clinical Trial

Official title:

Non-Interventional Study of Children Aged From 3 to 14 Years Suffering From Functional Gastrointestinal Complaints Classified According to the Rome Criteria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04029376
• Other study ID #: 20983
• Status: Completed
• Start date: April 1, 2007
• Est. completion date: October 1, 2008

Study information

• Verified date: September 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1032
• Est. completion date: October 1, 2008
• Est. primary completion date: October 1, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

The selection of the children to be documented was the sole responsibility of the physician whereby the information of the Rome III criteria on functional gastrointestinal diseases in children as well as the prescribing information on Iberogast could be consulted as guideline. Only the therapeutic necessity was determining for the use of all medicines. The treating physicians received standardised information regarding the ailment picture (Rome III criteria) before the beginning of the study and during the investigator meetings.

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

Drug:
• Iberogast®
The medication was applied 3 times 20 drops per day before or at meals with some liquid, ideally to one week insofar.

Locations

Country	Name	City	State
Germany	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 1 week
Primary	Global Assessment of the Efficacy by the Physicians	Treatment success assessed by physicians	Up to 1 week
Primary	Global Assessment of the Efficacy by the Children or Their Parents	Treatment success judged by children or their parents	Up to 1 week
Primary	Lost Attendance days	The number of lost attendance days kindergarten/school	Up to 1 week
Secondary	Global Assessment of the Tolerability by the Physician	The tolerability of Iberogast assessed by physician	Up to 1 week
Secondary	The number of subjects with adverse events	The number of subjects who had any adverse event during the study	Up to 1 week

External Links

•   Click here to find results for studies related to Bayer products