Clinical trial NCT04993989: A Pharmacy-based Study to Learn More About How Well Iberogast Works, How it Affects the Body, How it is Used, and User Satisfaction in Patients With Functional and Motility-related (Stomach and Bowel Movement-related) Gastrointestinal Diseases, Including Irritable Bowel Syndrome
Official title: Pharmacy-based Study on the Effectiveness, Tolerability, Usage Behavior and User Satisfaction of Iberogast® in Functional and Motility-related Gastrointestinal Diseases, Preferably Irritable Bowel Syndrome.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional and Motility Related Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional Dyspepsia
Keywords: Iberogast
Functional dyspepsia
Irritable bowel syndrome
Stomach mucosal inflammation
Pharmacy based survey
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2021-08-06
Enrollment: 843
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: German patients who used Iberogast for treatment of gastrointestinal complaints.

Brief summary: Researchers want to learn more about the day-to-day use of Iberogast in people who have functional and motility-related gastrointestinal (stomach and bowel) diseases.

Functional and motility-related stomach and bowel diseases are conditions in which the functionality of the gut, mainly the gut muscles or the gut/brain axis is disturbed. Functional and motility related stomach and bowel diseases cause symptoms like heartburn, cramps and u 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.

In this study, the researchers want to learn more about Iberogast, a plant-based treatment. Iberogast is available to treat stomach and bowel diseases such as FD and IBS.

Earlier studies with Iberogast have shown how well it works and how it affects the body. But, little is known about the day-to-day use of Iberogast and how satisfied patients are who take it. So in this study, the researchers want to learn more about Iberogast including:

* how well it works in day-to-day use
* how it affects the body, also referred to as tolerability
* how it is used day-to-day
* how safe it is
* how satisfied patients are who take it

To answer these questions, the researchers will collect information from pharmacies in Germany. Patients who get Iberogast from these pharmacies to help treat their gastrointestinal disease will complete a questionnaire before, during and after taking Iberogast. The researchers will use the results from the questionnaires to learn more about:

* the disease details of the patients who are taking Iberogast
* the patients' symptoms while taking Iberogast
* if the patients' symptoms change after taking Iberogast
* how satisfied patients are with Iberogast
* if the patients had adverse events

An adverse event is any medical problem that a participant has during a study.

This study will include patients in Germany who:

* have functional stomach and bowel symptoms or disorders like FD or IBS
* take Iberogast to treat symptoms of their stomach and bowel disease
* are able to complete the questionnaire

There will be no required tests or visits with a study doctor in this study. No treatments will be given as part of this study. The researchers will review information collected from patients who have decided for their own or by recommendation of their doctors or pharmacist to take Iberogast. The researchers will collect the results from the patient questionnaires from November 2017 to March 2018.


Eligibility criteria: Inclusion Criteria:

* Patients received a questionnaire, if all of the following applied:

  * Patients intent to use Iberogast® for the treatment of functional gastrointestinal symptoms (e.g. stomach pain, abdominal cramps, nausea, bloating, flatulence and heartburn) as well as defined functional dyspepsia (FD) and irritable bowel syndrome (IBS).
  * Patients suffered more from intestine-related complaints
  * Patients expressed their interest in participating in the study
  * Patients were willing and able to answer the questionnaire completely and plausibly

Exclusion Criteria:

* Patients did not receive a questionnaire, if

  * Patients did not currently use Iberogast® to treat gastrointestinal diseases such as irritable stomach and irritable bowel syndrome (medicine cabinet \& travel medicine cabinet) or bought the product for someone else
  * Patients did not give a specific reason for treatment
  * Patients did not show interest in participating
  * Patients suffered exclusively from diarrhea and constipation
  * Patients suffered exclusively from heartburn.

Primary outcomes:
measure: Onset of symptom improvement as assessed by patients
timeFrame: At baseline
measure: Symptom improvement as assessed by patients.
timeFrame: 7 days
measure: Effectiveness of Iberogast in comparison to other treatments as assessed by patient.
timeFrame: 7 days
measure: Number of participants with gastrointestinal complaints ,categorized by severity.
timeFrame: 7 days
measure: Patients´ usage behavior as assessed by patients.
timeFrame: At baseline
measure: Number of participants with adverse events.
timeFrame: 7 days
measure: Patients 'satisfaction as assessed by patients.
timeFrame: 7 days
Secondary outcomes:
measure: Descriptive analyses of demographic data.
timeFrame: At baseline
measure: Percentage of patients consulted physician for examination to clarify gastrointestinal complaints.
timeFrame: At baseline
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Many Locations
Study officials:
References: