Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE June 24, 2020
First Posted Date  ICMJE June 26, 2020
Last Update Posted Date June 26, 2020
Actual Study Start Date  ICMJE June 8, 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2020)
The effects of daily intake of Bif195 versus placebo [ Time Frame: before vs after 4 week intervention ]
Lanza Score obtained during endoscopy
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mapping the MoA Behind GI Protection From Bif195
Official Title  ICMJE 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
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Reduction of Small Intestinal Ulceration Risk
Intervention  ICMJE
  • Dietary Supplement: Bif195
    Active trial product with minimum 100 billion CFU daily dose
  • Other: Placebo
    Placebo similar to trial product but without Bif195
Study Arms  ICMJE
  • Placebo Comparator: Placebo arm
    Placebo arm. Similar trial product, but without Bif195 bacteria
    Intervention: Other: Placebo
  • Experimental: Bif195 arm
    Active trial product with minimum 100 billion CFU daily dose
    Intervention: Dietary Supplement: Bif195
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2020)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Brynjulf Mortensen, PhD +45 51805488 dkbrmo@chr-hansen.com
Contact: Nina Løn nina.loen@regionh.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04448847
Other Study ID Numbers  ICMJE HND-GI-036
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chr Hansen
Study Sponsor  ICMJE Chr Hansen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Filip Knop, Professor Center for Clinical Metabolic Research, Gentofte Hospital
PRS Account Chr Hansen
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP