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

NCT04029376 | Completed

• 1 other identifier: 20983
• Study Type: observational
• Target: 1,032
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (4)

• 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

• Global Assessment of the Efficacy by the Physicians

  Treatment success assessed by physicians

  Up to 1 week

• Global Assessment of the Efficacy by the Children or Their Parents

  Treatment success judged by children or their parents

  Up to 1 week

• Lost Attendance days

  The number of lost attendance days kindergarten/school

  Up to 1 week

Secondary Outcomes (2)

• Global Assessment of the Tolerability by the Physician

  Up to 1 week

• The number of subjects with adverse events

  Up to 1 week

Interventions

Iberogast® DRUG

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

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Male and female children aged between 3 and up to 14 years with Functional Gastrointestinal Complaints

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, Germany

Location

Related Links

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

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

iberogast

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 23, 2019
• Study Start: April 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

DE (1)