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

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

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.

Study Overview

• Status: Terminated
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Other: Bifidobacterium longum 35624

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).

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Düsseldorf, Nordrhein-Westfalen, Germany
      • Several General Practicioner and Gastroenterologists (Multicentric)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

IBS patients of general practicioners and gastroenterologists

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medice Arzneimittel Pütter GmbH & Co KG
• Collaborators: BioTeSys GmbH

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Actual): November 9, 2021
• Study Completion (Actual): November 9, 2021

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 6, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: 6630-0280-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No