Clinical trial NCT05389709: A Pharmacy-based Observational Study to Learn More About Iberogast Advance in the Real-world Setting
Official title: Pharmacy-based Non-interventional Study (NIS) With Iberogast® Advance (STW 5 II).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional Dyspepsia
Irritable Bowel Syndrome
Functional Dyspepsia
Keywords: Iberogast Advance
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-05-25
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: German patients who use Iberogast Advance for treatment of gastrointestinal complaints.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients with known hypersensitivity to any of the ingredients of Iberogast Advance
* Pregnant or lactating women

Primary outcomes:
measure: Single gastrointestinal symptoms intensity via a five point Likert scale assessed weekly.
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Descriptive analyses of patient characteristics data
timeFrame: At baseline
measure: Descriptive analyses of patient symptoms profile
timeFrame: At baseline
measure: Reason for using Iberogast Advance
timeFrame: At baseline
measure: Long term usage during the previous 6 months
timeFrame: At baseline
measure: Usual dosage applicated assessed weekly
timeFrame: Up to 6 weeks
measure: Onset of noticeable symptom relief after application of Iberogast Advance as assessed by patient weekly.
timeFrame: Up to 6 weeks
measure: Overall treatment effect of Iberogast Advance measured as course of gastrointestinal symptom intensity as assessed by patient
timeFrame: At week 6
measure: Change of symptoms after 6 weeks treatment/observation period via a five point Likert scale
timeFrame: Baseline to week 6
measure: Patients satisfaction as assessed by patients as assessed via a five point Likert scale.
timeFrame: At week 6
measure: Number of participants with gastrointestinal complaints ,categorized by severity.
timeFrame: At week 6
measure: Reason for early termination of Iberogast Advance
timeFrame: At week 6
measure: Tolerability as assessed by the patient
timeFrame: At week 6
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Many Locations
state: Many Locations
Study officials:
References: