NCT04859075

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

May 5, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2021

Completed
Last Updated

January 6, 2022

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

April 20, 2021

Last Update Submit

December 16, 2021

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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)

  • Severity score of irritable bowel syndrome compared to day 1

    assessed at day 1, day 29 and day 57

  • Efficacy & tolerability by physician

    assessed at day 57

  • Efficacy & tolerability by participant

    assessed at day 57

  • Interference of IBS symptoms with general life

    assessed at day 1, day 29 and day 57

Interventions

Bifidobacterium longum 35624OTHER

1 capsule daily

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

IBS patients of general practicioners and gastroenterologists

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Several General Practicioner and Gastroenterologists (Multicentric)

Düsseldorf, North Rhine-Westphalia, Germany

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 26, 2021

Study Start

May 5, 2021

Primary Completion

November 9, 2021

Study Completion

November 9, 2021

Last Updated

January 6, 2022

Record last verified: 2021-12

Locations

DE(1)