NCT04447924

Brief Summary

To investigate if a daily dose of minimum 15 billion CFU of Bif195 reduces the risk of small-intestinal tissue damage in an Ibuprofen challenge model as assessed by video capsule endoscopy in a healthy US population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

12 months

First QC Date

June 24, 2020

Last Update Submit

August 25, 2021

Conditions

Reduction of Small Intestinal Ulceration Risk

Outcome Measures

Primary Outcomes (1)

  • Lewis score area-under-the-curve for Bif195 vs Placebo

    The effect of Bif195 versus placebo on small intestinal mucosal damage during a 6-week Ibuprofen challenge measured as the area-under-the-curve of the Lewis scores obtained from all video capsule endoscopies between Visit 2 (randomization) and Visit 6 (end of treatment).

    6 weeks

Study Arms (2)

Placebo arm

PLACEBO COMPARATOR

Placebo arm. Similar trial product, but without Bif195 bacteria

Other: Placebo

Bif195 arm

EXPERIMENTAL

Active trial product with minimum 15 billion CFU daily dose

Dietary Supplement: Bif195

Interventions

Bif195DIETARY_SUPPLEMENT

Daily intake of Bif195 dietary supplement

Bif195 arm
PlaceboOTHER

Daily intake of Placebo

Placebo arm

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent
  • Healthy and without any gastrointestinal pain or other significant symptoms
  • Age 18 - 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

Study Sites (1)

Atlantia Food Clinical Trials

Chicago, Illinois, 60611, United States

Location

Study Officials

  • Eamonn Quigley, Professor

    Houston Methodist Gastroenterology Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2020

First Posted

June 25, 2020

Study Start

June 22, 2020

Primary Completion

June 10, 2021

Study Completion

June 10, 2021

Last Updated

August 26, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)