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

Terminated

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT04859075
• Lead Sponsor: Medice Arzneimittel Pütter GmbH & Co KG

Brief 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).

Study Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-26
• Study Start: 2021-05-05
• Primary Completion: 2021-11-09
• Study Completion: 2021-11-09
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2022-01-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

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 Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative change in overall IBS symptoms compared to day 1 (sum of abdominal pain, bloating, gas, difficulty in defecating/constipation and urgency/diarrhoea symptom scores)	assessed weekly over 8 weeks (from day 1 to day 57)	rated by participant on a 6-point Likert scale (from 0 "no symptoms" to 5 "very severe")

Secondary Outcome Measures

Name	Time	Method
Efficacy & tolerability by participant	assessed at day 57	rated on a 6-point Likert scale (from 1 "very good" to 6 "unsatisfactory")
Relative change in the individual IBS symptoms abdominal pain, gas, bloating, difficulty in defecating/constipation and urgency/diarrhoea compared to day 1	assessed weekly over 8 weeks (from day 1 to day 57)	rated by participant on a 6-point Likert scale (from 0 "no symptoms" to 5 "very severe")
Severity score of irritable bowel syndrome compared to day 1	assessed at day 1, day 29 and day 57	German IBS severity scoring system questionnaire by the participant (IBS-SSS, scoring from 0 to 500; higher scores indicating higher severity of IBS symptoms)
Efficacy & tolerability by physician	assessed at day 57	rated on a 6-point Likert scale (from 1 "very good" to 6 "unsatisfactory")
Interference of IBS symptoms with general life	assessed at day 1, day 29 and day 57	rated by the participant by question 5 of the German IBS-SSS questionnaire (scoring from 0 to 100; higher scores indicating higher interference with general life)

Trial Locations

Locations (1)

Several General Practicioner and Gastroenterologists (Multicentric); 🇩🇪 Düsseldorf, Nordrhein-Westfalen, Germany