Clinical trial NCT04859075: Efficacy and Safety of Alflorex Bei Reizdarm in Patients With Irritable Bowel Syndrome
Official title: Efficacy and Safety of Alflorex® Bei Reizdarm, a Probiotic Containing Bifidobacterium Longum 35624®, in Patients With Irritable Bowel Syndrome in Medical Practice
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Irritable Bowel Syndrome
Lead sponsor: Medice Arzneimittel Pütter GmbH & Co KG
Sponsor class: INDUSTRY
Collaborators: name: BioTeSys GmbH
First posted: 2021-04-26
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IBS patients of general practicioners and gastroenterologists

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).

Eligibility criteria: 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:

-

Primary outcomes:
measure: 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)
timeFrame: assessed weekly over 8 weeks (from day 1 to day 57)
Secondary outcomes:
measure: Relative change in the individual IBS symptoms abdominal pain, gas, bloating, difficulty in defecating/constipation and urgency/diarrhoea compared to day 1
timeFrame: assessed weekly over 8 weeks (from day 1 to day 57)
measure: Severity score of irritable bowel syndrome compared to day 1
timeFrame: assessed at day 1, day 29 and day 57
measure: Efficacy & tolerability by physician
timeFrame: assessed at day 57
measure: Efficacy & tolerability by participant
timeFrame: assessed at day 57
measure: Interference of IBS symptoms with general life
timeFrame: assessed at day 1, day 29 and day 57
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Several General Practicioner and Gastroenterologists (Multicentric)
state: Nordrhein-Westfalen
Study officials:
References: