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Functional gastrointestinal disorders such as irritable bowel syndrome and functional dyspepsia, Irritable bowel syndrome, Functional dyspepsia

A pharmacy-based observational study to learn more about Iberogast Advance in the real-world setting

Trial purpose

This is an observational study in which data from people with functional gastrointestinal disorders who decide on their own or by recommendation of their doctors or pharmacists to take Iberogast Advance are collected and studied. In observational studies, only observations are made without specified advice or interventions.

Functional stomach and bowel (or gastrointestinal) disorders are conditions in which the functionality of the gut, mainly the gut muscles or the gut/brain axis, is disturbed. Functional stomach and bowel disorders cause symptoms like heartburn, cramps and pain of the upper and middle part of the belly, also known as functional dyspepsia (FD) and irritable bowel syndrome (IBS). IBS affects predominantly the lower digestive system and causes symptoms like pain of the belly, cramps, bloating, diarrhea, and constipation.

Iberogast Advance is already available in German pharmacies without prescription for patients with gastrointestinal disorders such as FD and IBS. It contains herb extracts that work against inflammation, are calming, and protect the mucosa (innermost layer of the gastrointestinal tract). Earlier controlled studies with Iberogast Advance have shown how well it works and how it affects the body. Since Iberogast Advance is only available since October 2020, there is no information on its use in the real-world setting yet.

Therefore, the study researchers want to collect data on the use of Iberogast Advance in the real-world setting.

To do this, people with long-term and repeated functional gastrointestinal symptoms who purchase Iberogast Advance from participating pharmacies across Germany will be asked to fill out a questionnaire optionally covering 6 weeks of treatment. The participants will take Iberogast Advance as recommended in the product information.

The main purpose of this study is to see how well Iberogast Advance works and is perceived in the real-world setting. Participants will record how they experience a change of their gastrointestinal symptoms (assessed single-symptom-based) from start and during 6 weeks of treatment. Researchers will then compare the differences and analyze treatment effects.

The researchers will additionally collect information on usage behavior, characteristics of the patients, their symptoms, tolerability and their satisfaction with Iberogast Advance.

There will be no required tests or visits with a study doctor in this study. The researchers will collect the results of the patient questionnaires from Jun 2022 to January 2023.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - Adult female or male subject aged ≥ 18
    - Decision to initiate treatment with Iberogast Advance was made as per pharmacist’s routine recommendation practice/by the subject
    - Subject purchases Iberogast Advance for his own use
    - Not pregnant or lactating
    - Not hypersensitive to any of the ingredients of Iberogast Advance
  • - Patients with known hypersensitivity to any of the ingredients of Iberogast Advance
    - Pregnant or lactating women

Trial summary

Enrollment Goal
184
Trial Dates
June 2022 - May 2023
Phase
N/A
Could I Receive a placebo
No
Products
Iberogast N (STW5-II, BAY98-7410)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Many LocationsMany Locations, Germany

Primary Outcome

  • Single gastrointestinal symptoms intensity via a five point Likert scale assessed weekly.
    Patients assessed intensity on 5 point Likert scale as 0=no symptom; 1=mild symptom; 2= moderate symptom; 3=strong symptom; 4= unbearable symptom.
    date_rangeTime Frame:
    Up to 6 weeks

Secondary Outcome

  • Descriptive analyses of patient characteristics data
    date_rangeTime Frame:
    At baseline
  • Descriptive analyses of patient symptoms profile
    date_rangeTime Frame:
    At baseline
  • Reason for using Iberogast Advance
    date_rangeTime Frame:
    At baseline
  • Long term usage during the previous 6 months
    date_rangeTime Frame:
    At baseline
  • Usual dosage applicated assessed weekly
    date_rangeTime Frame:
    Up to 6 weeks
  • Onset of noticeable symptom relief after application of Iberogast Advance as assessed by patient weekly.
    date_rangeTime Frame:
    Up to 6 weeks
  • Overall treatment effect of Iberogast Advance measured as course of gastrointestinal symptom intensity as assessed by patient
    date_rangeTime Frame:
    At week 6
  • Change of symptoms after 6 weeks treatment/observation period via a five point Likert scale
    Patients assessed intensity on 5 point Likert scale as 0=no symptom; 1=mild symptom; 2= moderate symptom; 3=strong symptom; 4= unbearable symptom.
    date_rangeTime Frame:
    Baseline to week 6
  • Patients satisfaction as assessed by patients as assessed via a five point Likert scale.
    Patients assessed intensity on 5 point Likert scale as 0=no symptom; 1=mild symptom; 2= moderate symptom; 3=strong symptom; 4= unbearable symptom.
    date_rangeTime Frame:
    At week 6
  • Number of participants with gastrointestinal complaints ,categorized by severity.
    date_rangeTime Frame:
    At week 6
  • Reason for early termination of Iberogast Advance
    date_rangeTime Frame:
    At week 6
  • Tolerability as assessed by the patient
    Patients assessed tolerability by using very good; Good; Moderate; Bad; Very bad; Missing values.
    date_rangeTime Frame:
    At week 6

Trial design

Pharmacy-based non-interventional study (NIS) with Iberogast® Advance (STW 5 II).
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A