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

NCT ID: NCT03910322

Last Updated: 2020-06-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-19
• Study Completion Date: 2019-12-01

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.

Conditions

Reduction of Small Intestinal Ulceration Risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo arm. Similar trial product, but without Bif195 bacteria

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Low-dose Bif195

Active trial product with minimum 15 billion CFU daily dose

Group Type: EXPERIMENTAL

Bif195

Intervention Type: DIETARY_SUPPLEMENT

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

High-dose Bif195

Active trial product with minimum 50 billion CFU daily dose

Group Type: EXPERIMENTAL

Bif195

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Bif195

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atlantia Food Clinical Trials

INDUSTRY

Sponsor Role: collaborator

Chr Hansen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eamonn Quigley, Professor

Role: PRINCIPAL_INVESTIGATOR

Houston Methodist Gastroenterology Associates

Locations

Atlantia Food Clinical Trials

Chicago, Illinois, United States

Countries

United States

Other Identifiers

HND-GI-035

Identifier Type: -

Identifier Source: org_study_id