Mapping the MoA Behind GI Protection From Bif195 | NCT04448847

Studies
Mapping the MoA Behind GI Protection From Bif195

NCT04448847

Sponsor

Chr Hansen

Status

Completed

Last Update Posted

Apr 24, 2023Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Reduction of Small Intestinal Ulceration Risk

Interventions

Bif195
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 8, 2020Actual

Primary Completion Date

Jan 12, 2021Actual

Completion Date

Jan 12, 2021Actual

First Submitted Date

Jun 24, 2020

First Submission Date that Met QC Criteria

Jun 24, 2020

First Posted Date

Jun 26, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2023

Last Update Posted Date

Apr 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo arm	Placebo Comparator	Placebo arm. Similar trial product, but without Bif195 bacteria	Other: Placebo
Bif195 arm	Experimental	Active trial product with minimum 100 billion CFU daily dose	Dietary Supplement: Bif195

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bif195	Dietary Supplement	Active trial product with minimum 100 billion CFU daily dose	Bif195 arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The effects of daily intake of Bif195 versus placebo	Lanza Score obtained during endoscopy	before vs after 4 week intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Filip Knop, Professor	Center for Clinical Metabolic Research, Gentofte Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Clinical Metabolic Research, Gentofte Hospital		Hellerup		2900	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38036761	Derived	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 18, 2020	Apr 20, 2023	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Feb 12, 2021	Apr 20, 2023	SAP_001.pdf