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NCT Number: NCT04029376

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

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.

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Key information

Conditions

Functional Gastrointestinal Disorders Digestive System Diseases Gastrointestinal Diseases

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iberogast®

Drug

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

Primary outcomes

  1. Gastrointestinal Symptoms Profile (GIS) Score

    Time frame: 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.

  2. Global Assessment of the Efficacy by the Physicians

    Time frame: Up to 1 week

    Treatment success assessed by physicians

  3. Global Assessment of the Efficacy by the Children or Their Parents

    Time frame: Up to 1 week

    Treatment success judged by children or their parents

  4. Lost Attendance days

    Time frame: Up to 1 week

    The number of lost attendance days kindergarten/school

Secondary outcomes

  1. Global Assessment of the Tolerability by the Physician

    Time frame: Up to 1 week

    The tolerability of Iberogast assessed by physician

  2. The number of subjects with adverse events

    Time frame: Up to 1 week

    The number of subjects who had any adverse event during the study

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 23, 2019
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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