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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Other: Bifidobacterium longum 35624


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Bifidobacterium longum 35624|1 capsule daily|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | rated by participant on a 6-point Likert scale (from 0 no symptoms to 5 very severe) | assessed weekly over 8 weeks (from day 1 to day 57) | 

Secondary Outcome Measures

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