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

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Colic

Lactose Intolerance

Treatment

N/A

Clinical Study ID

NCT04859075

6630-0280-01

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Adult, diagnosed IBS patients with typical IBS symptoms (abdominal pain, bloating, gas,constipation or diarrhea) and physician's recommendation to take the study medication (probiotic with B. longum 35624) for 8 weeks

Exclusion

Exclusion Criteria:

Study Design

May 05, 2021

November 09, 2021

Study 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).

Connect with a study center

Several General Practicioner and Gastroenterologists (Multicentric)
Düsseldorf, Nordrhein-Westfalen
Germany
Site Not Available

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