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.
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 Type
OBSERVATIONAL
Enrollment
37
1 capsule daily
Several General Practicioner and Gastroenterologists (Multicentric)
Düsseldorf, North Rhine-Westphalia, Germany
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")
Time frame: assessed weekly over 8 weeks (from day 1 to day 57)
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")
Time frame: 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)
Time frame: 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")
Time frame: assessed at day 57
Efficacy & tolerability by participant
rated on a 6-point Likert scale (from 1 "very good" to 6 "unsatisfactory")
Time frame: 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)
Time frame: assessed at day 1, day 29 and day 57
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