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Mapping the MoA Behind GI Protection From Bif195 (PIP-M)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04448847
Recruitment Status : Recruiting
First Posted : June 26, 2020
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Chr Hansen

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.


Condition or disease Intervention/treatment Phase
Reduction of Small Intestinal Ulceration Risk Dietary Supplement: Bif195 Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: a randomised, double-blinded, placebo-controlled, cross-over trial
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : June 8, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo arm
Placebo arm. Similar trial product, but without Bif195 bacteria
Other: Placebo
Placebo similar to trial product but without Bif195

Experimental: Bif195 arm
Active trial product with minimum 100 billion CFU daily dose
Dietary Supplement: Bif195
Active trial product with minimum 100 billion CFU daily dose




Primary Outcome Measures :
  1. The effects of daily intake of Bif195 versus placebo [ Time Frame: before vs after 4 week intervention ]
    Lanza Score obtained during endoscopy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04448847


Contacts
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Contact: Brynjulf Mortensen, PhD +45 51805488 dkbrmo@chr-hansen.com
Contact: Nina Løn nina.loen@regionh.dk

Locations
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Denmark
Center for Clinical Metabolic Research, Gentofte Hospital Recruiting
Hellerup, Denmark, 2900
Contact: Nina Løn       nina.loen@regionh.dk   
Contact: Filip Knop, Professor       filip.krag.knop.01@regionh.dk   
Sponsors and Collaborators
Chr Hansen
Investigators
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Principal Investigator: Filip Knop, Professor Center for Clinical Metabolic Research, Gentofte Hospital
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Responsible Party: Chr Hansen
ClinicalTrials.gov Identifier: NCT04448847    
Other Study ID Numbers: HND-GI-036
First Posted: June 26, 2020    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ulcer
Pathologic Processes