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Efficacy and Safety of Alflorex Bei Reizdarm in Patients With Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:
Efficacy and Safety of Alflorex® Bei Reizdarm, a Probiotic Containing Bifidobacterium Longum 35624®, in Patients With Irritable Bowel Syndrome in Medical Practice

Clinical Trial Summary

This Post-Market Clinical-Follow Up (PMCF) study gains data on the efficacy and safety of "Alflorex bei Reizdarm", a probiotic based on Bifidobacterium longum 35624, in the daily use by irritable bowel syndrome (IBS) patients. The aim of this study is the observation of the influence of "Alflorex bei Reizdarm" on typical symptoms, severity score and quality of life of IBS patients in medical practice and everyday use.

Clinical Trial Description

This Post-Market Clinical-Follow Up (PMCF) study observes adult patients with irritable bowel syndrome (IBS) which receive "Alflorex bei Reizdarm", a probiotic based on Bifidobacterium longum 35624, for 8 weeks by recommendation of their physician. IBS symptoms are recorded on a weekly basis by the participants. IBS severity score, interference with general life and safety parameters are also recorded. Primary objective is the assessment of the change in overall IBS symptoms (sum of abdominal pain, bloating, gas, difficulty in defecating/constipation and urgency/diarrhoea). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04859075
Study type Observational
Source Medice Arzneimittel Pütter GmbH & Co KG
Contact
Status Terminated
Phase
Start date May 5, 2021
Completion date November 9, 2021
View Details
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