Irritable Bowel SyndromeNCT04859075
Efficacy and Safety of Alflorex Bei Reizdarm in Patients With Irritable Bowel Syndrome
An observational study of Irritable Bowel Syndrome, run by Medice Arzneimittel Pütter GmbH & Co KG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Bifidobacterium longum 35624
- Type of treatment
- Pill or oral medicine
- How many people
- 37 participants
- Where
- 1 siteGermany
- Study dates
- 5 May 2021to 9 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: IBS patients of general practicioners and gastroenterologists
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Germany1 site
Several General Practicioner and Gastroenterologists (Multicentric)
Düsseldorf, North Rhine-Westphalia
About this study
Official title: 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.
Read the 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).
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Bifidobacterium longum 35624
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium longum 35624Other
1 capsule daily
What is being measured
The primary outcome is the main question the study is designed to answer.
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")
Measured: 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
rated by participant on a 6-point Likert scale (from 0 "no symptoms" to 5 "very severe")
Measured: 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)
Measured: 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")
Measured: assessed at day 57
Efficacy & tolerability by participant
rated on a 6-point Likert scale (from 1 "very good" to 6 "unsatisfactory")
Measured: 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)
Measured: assessed at day 1, day 29 and day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start5 May 2021
- Primary completion9 Nov 2021
- Study completion9 Nov 2021
Why it stopped: economic reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medice Arzneimittel Pütter GmbH & Co KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859075
- Sponsor's protocol ID
- 6630-0280-01
- Status last verified
- Dec 2021
- First submitted
- 20 Apr 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Alflorex® Bei Reizdarm, a Probiotic Containing Bifidobacterium Longum 35624®, in Patients With Irritable Bowel Syndrome in Medical Practice
- ClinicalTrials.gov ID
- NCT04859075
- Acronym / sponsor ID
- 6630-0280-01
- Conditions
- Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: economic reasons
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Medice Arzneimittel Pütter GmbH & Co KGIndustry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Study start
- 5 May 2021 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- IBS patients of general practicioners and gastroenterologists
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium longum 356241 capsule daily | Other | – |
Primary outcome
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)
Time frame: assessed weekly over 8 weeks (from day 1 to day 57)
rated by participant on a 6-point Likert scale (from 0 "no symptoms" to 5 "very severe")
5 secondary outcomes
Relative change in the individual IBS symptoms abdominal pain, gas, bloating, difficulty in defecating/constipation and urgency/diarrhoea compared to day 1
Time frame: assessed weekly over 8 weeks (from day 1 to day 57)
Severity score of irritable bowel syndrome compared to day 1
Time frame: assessed at day 1, day 29 and day 57
Efficacy & tolerability by physician
Time frame: assessed at day 57
Efficacy & tolerability by participant
Time frame: assessed at day 57
Interference of IBS symptoms with general life
Time frame: assessed at day 1, day 29 and day 57
Results and safety
The study was stopped early (reason given: economic reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Medice Arzneimittel Pütter GmbH & Co KG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: economic reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: assessed weekly over 8 weeks (from day 1 to day 57)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.