NCT04859075

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 37 (actual)
• Sponsor: Medice Arzneimittel Pütter GmbH & Co KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
OTHER	Bifidobacterium longum 35624	1 capsule daily

Timeline

• Start date: 2021-05-05
• Primary completion: 2021-11-09
• Completion: 2021-11-09
• First posted: 2021-04-26
• Last updated: 2022-01-06

Locations

1 site across 1 country: Germany