Irritable Bowel Syndrome Clinical Trial
Official title:
Efficacy and Safety of Alflorex® Bei Reizdarm, a Probiotic Containing Bifidobacterium Longum 35624®, in Patients With Irritable Bowel Syndrome in Medical Practice
| NCT number | NCT04859075 |
| Other study ID # | 6630-0280-01 |
| Secondary ID | |
| Status | Terminated |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 5, 2021 |
| Est. completion date | November 9, 2021 |
| Verified date | December 2021 |
| Source | Medice Arzneimittel Pütter GmbH & Co KG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 37 |
| Est. completion date | November 9, 2021 |
| Est. primary completion date | November 9, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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: - |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Several General Practicioner and Gastroenterologists (Multicentric) | Düsseldorf | Nordrhein-Westfalen |
| Lead Sponsor | Collaborator |
|---|---|
| Medice Arzneimittel Pütter GmbH & Co KG | BioTeSys GmbH |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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) | |
| Secondary | 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 | |
| Secondary | Efficacy & tolerability by physician | rated on a 6-point Likert scale (from 1 "very good" to 6 "unsatisfactory") | assessed at day 57 | |
| Secondary | Efficacy & tolerability by participant | rated on a 6-point Likert scale (from 1 "very good" to 6 "unsatisfactory") | assessed at day 57 | |
| Secondary | 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 |
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