Irritable Bowel Syndrome
Conditions
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).
Interventions
1 capsule daily
Sponsors
BioTeSys GmbH
Medice Arzneimittel Pütter GmbH & Co KG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Efficacy & tolerability by participant | 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) |
Countries
Germany
Outcome results
None listed