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The Effect of a Probiotic Strain on Aspirin-induced GI Damage (PIP-L)

Primary Purpose

Reduction of Small Intestinal Ulceration Risk

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bif195

Placebo

About this trial

This is an interventional prevention trial for Reduction of Small Intestinal Ulceration Risk

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Written informed consent
Healthy and without any gastrointestinal discomfort/pain symptoms
Age 40-60 years of both genders (aim of minimum 1/3 of each gender in each arm)
Willing and able to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial

Exclusion Criteria:

Abdominal surgery which, as judged by the investigator, might affect the GI function (except appendectomy and cholecystectomy)
History of peptic ulcer disease
Any known bleeding disorder
Allergy to ASA
Resting diastolic blood pressure ≥ 95 mmHg
Resting systolic blood pressure ≥ 150 mmHg
A current diagnosis of psychiatric disease
Systemic use of antibiotics, steroids (except contraceptives) or antimicrobial medication in the last 2 months
Daily usage of non-steroidal anti-inflammatory drugs in the last 2 months or incidental use in the last 2 weeks prior to screening (ASA, Ibuprofen, Diclofenac, Naproxen, Celecoxib, Mefenamic acid, Etoricoxib, Indometacin)
Usage of medications, except contraceptives, in the last 2 weeks prior to screening
Diagnosed inflammatory gastrointestinal disease and/or irritable bowel syndrome
Any other disease that, by the Investigators discretion, could interfere with the intestinal barrier function of the subject
Participation in other clinical trials in the past 2 months prior to screening
Regular use of probiotics in the last month
Smoking and/or frequent use of other nicotine products
Desire and/or plans on changing current diet and/or exercise regime during the participation of this trial
Use of laxatives, anti-diarrheals, anti-cholinergics and proton pump inhibitors within last 2 months prior to screening
Use of immunosuppressant drugs within last 4 weeks prior to screening
For Women: Pregnancy or lactation

Sites / Locations

Atlantia Food Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Low-dose Bif195

High-dose Bif195

Arm Description

Placebo arm. Similar trial product, but without Bif195 bacteria

Active trial product with minimum 15 billion CFU daily dose

Active trial product with minimum 50 billion CFU daily dose

Outcomes

Primary Outcome Measures

primary endpoint - Lewis score high dose Bif195 vs Placebo

The effect of high-dose Bif195 versus placebo on small intestinal mucosal damage during a 6-week ASA 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).

Secondary Outcome Measures

Full Information

NCT ID

NCT03910322

First Posted

April 9, 2019

Last Updated

June 24, 2020

Sponsor

Chr Hansen

Collaborators

Atlantia Food Clinical Trials

1. Study Identification

Unique Protocol Identification Number

NCT03910322

Brief Title

The Effect of a Probiotic Strain on Aspirin-induced GI Damage

Acronym

PIP-L

Official Title

The Effect of Daily Intake of Two Different Doses of Bif195 on Small-intestinal Damage Induced by Acetylsalicylic Acid- a Randomized, Double-blind, Placebo-controlled, Three-armed, Parallel Group Trial in Healthy Volunteers.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Terminated

Why Stopped

Decision made by Sponsor

Study Start Date

August 19, 2019 (Actual)

Primary Completion Date

December 1, 2019 (Actual)

Study Completion Date

December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chr Hansen

Collaborators

Atlantia Food Clinical Trials

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The primary objective of this trial is to investigate if a daily dose of minimum 50 billion CFU of Bif195 reduces the risk of small-intestinal tissue damage in an acetylsalicylic acid challenge model as assessed by video capsule endoscopy in a healthy US population aged 40 - 60 years.

Detailed Description

This trial is a single-site, randomized, double-blind, placebo-controlled, three-armed, parallel-group trial in healthy volunteers aged 40 - 60 years. The trial will investigate the effect of daily intake of the probiotic strain Bif195 in two different doses or placebo when co-administered to daily intake of 300mg of Acetylsalicylic Acid (ASA). The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where Bif195/placebo and ASA is co-administered. Subjects will participate in the trial for a total duration of 8 weeks including the run-in phase. Besides the screening visit, the trial will consist of 5 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. After baseline assessments at Visit 2, subjects will start daily intake of 300mg ASA and also be randomly assigned to 6-weeks daily intake of low or high-dose active (Bif195) or placebo product in a ratio of 1:1:1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Reduction of Small Intestinal Ulceration Risk

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo arm. Similar trial product, but without Bif195 bacteria

Arm Title

Low-dose Bif195

Arm Type

Experimental

Arm Description

Active trial product with minimum 15 billion CFU daily dose

Arm Title

High-dose Bif195

Arm Type

Experimental

Arm Description

Active trial product with minimum 50 billion CFU daily dose

Intervention Type

Dietary Supplement

Intervention Name(s)

Bif195

Intervention Description

Two different doses of the bacterial strain Bif195 is compared to placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

primary endpoint - Lewis score high dose Bif195 vs Placebo

Description

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent Healthy and without any gastrointestinal discomfort/pain symptoms Age 40-60 years of both genders (aim of minimum 1/3 of each gender in each arm) Willing and able to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial Exclusion Criteria: Abdominal surgery which, as judged by the investigator, might affect the GI function (except appendectomy and cholecystectomy) History of peptic ulcer disease Any known bleeding disorder Allergy to ASA Resting diastolic blood pressure ≥ 95 mmHg Resting systolic blood pressure ≥ 150 mmHg A current diagnosis of psychiatric disease Systemic use of antibiotics, steroids (except contraceptives) or antimicrobial medication in the last 2 months Daily usage of non-steroidal anti-inflammatory drugs in the last 2 months or incidental use in the last 2 weeks prior to screening (ASA, Ibuprofen, Diclofenac, Naproxen, Celecoxib, Mefenamic acid, Etoricoxib, Indometacin) Usage of medications, except contraceptives, in the last 2 weeks prior to screening Diagnosed inflammatory gastrointestinal disease and/or irritable bowel syndrome Any other disease that, by the Investigators discretion, could interfere with the intestinal barrier function of the subject Participation in other clinical trials in the past 2 months prior to screening Regular use of probiotics in the last month Smoking and/or frequent use of other nicotine products Desire and/or plans on changing current diet and/or exercise regime during the participation of this trial Use of laxatives, anti-diarrheals, anti-cholinergics and proton pump inhibitors within last 2 months prior to screening Use of immunosuppressant drugs within last 4 weeks prior to screening For Women: Pregnancy or lactation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eamonn Quigley, Professor

Organizational Affiliation

Houston Methodist Gastroenterology Associates

Official's Role

Principal Investigator

Facility Information:

Facility Name

Atlantia Food Clinical Trials

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Effect of a Probiotic Strain on Aspirin-induced GI Damage

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