Mapping the MoA Behind GI Protection From Bif195
PIP-M
Discovering the Mechanisms of Action for the In-vivo Protection of Aspirin-induced Enteropathy by Bifidobacterium Breve Bif195 in Man - a Randomised, Double-blinded, Placebo-controlled, Cross-over Trial in Healthy Volunteers
1 other identifier
interventional
25
1 country
1
Brief Summary
The trial will investigate effects of daily intake of the bacterial strain Bif195 or placebo when co-administered to once-daily oral intake of 300 mg of Acetylsalicylic Acid (ASA). The trial includes a run-in period of two weeks duration followed by a 4-week intervention period in which Bif195/placebo and ASA are co-administered. This period is followed by a 6-week wash-out period before a new 4-week period is performed with a cross-over Bif195/placebo intervention as well as ASA co-administration. Bif195 and placebo interventions are performed double-blinded in randomised order in a cross-over fashion for each subject.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2020
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
June 8, 2020
CompletedFirst Submitted
Initial submission to the registry
June 24, 2020
CompletedFirst Posted
Study publicly available on registry
June 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2021
CompletedApril 24, 2023
April 1, 2023
7 months
June 24, 2020
April 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The effects of daily intake of Bif195 versus placebo
Lanza Score obtained during endoscopy
before vs after 4 week intervention
Study Arms (2)
Placebo arm
PLACEBO COMPARATORPlacebo arm. Similar trial product, but without Bif195 bacteria
Bif195 arm
EXPERIMENTALActive trial product with minimum 100 billion CFU daily dose
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent
- Healthy and without any gastrointestinal discomfort/pain or other significant symptoms
- Age ≥ 18 and ≤ 40 years
- Willing to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chr Hansenlead
Study Sites (1)
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, 2900, Denmark
Related Publications (1)
Lon N, Engel S, Damholt A, Mortensen B, Haaber AB, Wellejus A, Knop FK. Bifidobacterium breve Bif195 ameliorates aspirin-induced gastric mucosal damage: A randomised, double blind, placebo-controlled crossover trial. Aliment Pharmacol Ther. 2024 Feb;59(3):341-349. doi: 10.1111/apt.17817. Epub 2023 Nov 30.
PMID: 38036761DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Filip Knop, Professor
Center for Clinical Metabolic Research, Gentofte Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- a randomised, double-blinded, placebo-controlled, cross-over trial
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2020
First Posted
June 26, 2020
Study Start
June 8, 2020
Primary Completion
January 12, 2021
Study Completion
January 12, 2021
Last Updated
April 24, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share