- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04448847
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
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Subjects will participate in the trial for a total duration of approximately 17 weeks including the run-in phase. Besides the screening visit, the trial will consist of 4 visits.
After having given their written informed consent, subjects will complete the screening procedures to evaluate their eligibility for participation in the trial and complete a run-in period of two weeks duration to washout possible pre-trial probiotics and/or use of medication. On the morning of day 4 after baseline assessments at Visit 2, all subjects will start daily intake of 300 mg ASA in combination with Bif195 or placebo in a ratio of 1:1 according to the randomisation performed at Visit 2.
At visit 2 - 5, all subjects will be biopsied from the upper small intestine and the ventricle during a gastroscopy procedure. At each of these 4 visits, 6 biopsies will be taken from pre-specified locations in the duodenum and 2 biopsies will be taken from the ventricle (approximately 5 mg each). Luminal fluids will also be collected during the gastroscopy (approximately 2 ml per visit). One venous blood sample (of 20 ml per visit) will also be collected at each of these visits.
The analysis on biopsies and luminal fluid samples will include a combination of transcriptomic, microbiome, proteomics and metabolomics analysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hellerup, Denmark, 2900
- Center for Clinical Metabolic Research, Gentofte Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• 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
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo arm
Placebo arm.
Similar trial product, but without Bif195 bacteria
|
Placebo similar to trial product but without Bif195
|
Experimental: Bif195 arm
Active trial product with minimum 100 billion CFU daily dose
|
Active trial product with minimum 100 billion CFU daily dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The effects of daily intake of Bif195 versus placebo
Time Frame: before vs after 4 week intervention
|
Lanza Score obtained during endoscopy
|
before vs after 4 week intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Filip Knop, Professor, Center for Clinical Metabolic Research, Gentofte Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HND-GI-036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Reduction of Small Intestinal Ulceration Risk
-
Chr HansenCompletedReduction of Small Intestinal Ulceration RiskUnited States
-
Chr HansenAtlantia Food Clinical TrialsTerminatedReduction of Small Intestinal Ulceration RiskUnited States
-
Nova Scotia Health AuthorityPfizer; Cape Breton District Health AuthorityCompletedCardiovascular Risk Reduction of Having a Coronary EventCanada
-
University of JenaCompletedReduction of Cardiovascular Risk FactorsGermany
-
Brown UniversityActive, not recruitingPrevention or Reduction of HIV Risk Behavior | Prevention or Reduction of Intimate Partner ViolenceSouth Africa
-
Tzu-Ting HuangCompletedRisk Reduction Behavior | Reduce Risk of DementiaTaiwan
-
Universitätsklinikum Hamburg-EppendorfLithuanian University of Health Sciences; Örebro University, Sweden; University... and other collaboratorsRecruitingReduction of Intestinal Inflammatory ActivityGermany
-
Johns Hopkins Bloomberg School of Public HealthRakai Health Sciences ProgramCompletedHIV | Risk Reduction Behavior | Physical Abuse of Adult (If Focus of Attention is on Victim) | Sexual Abuse of Adult (If Focus of Attention is on Victim)Uganda
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedSmall Intestinal Adenocarcinoma | Stage III Small Intestinal Adenocarcinoma AJCC v8 | Stage IIIA Small Intestinal Adenocarcinoma AJCC v8 | Stage IIIB Small Intestinal Adenocarcinoma AJCC v8 | Stage IV Small Intestinal Adenocarcinoma AJCC v8 | Ampulla of Vater Adenocarcinoma | Stage III Ampulla... and other conditionsUnited States
-
San Raffaele UniversityFondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy; Ospedale... and other collaboratorsRecruitingColorectal Cancer | Diet Habit | Risk Reduction | Early Onset Colorectal CancerUnited States, Finland, Germany, Italy, Norway, Spain
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy