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

NCT03910322 | Terminated

• 1 other identifier: HND-GI-035
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Reduction of Small Intestinal Ulceration Risk

Outcome Measures

Primary Outcomes (1)

• 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).

  6 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo arm. Similar trial product, but without Bif195 bacteria

Dietary Supplement: Placebo

Low-dose Bif195

EXPERIMENTAL

Active trial product with minimum 15 billion CFU daily dose

Dietary Supplement: Bif195

High-dose Bif195

EXPERIMENTAL

Active trial product with minimum 50 billion CFU daily dose

Dietary Supplement: Bif195

Interventions

Bif195 DIETARY_SUPPLEMENT

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

High-dose Bif195; Low-dose Bif195

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chr Hansen: lead
• Atlantia Food Clinical Trials: collaborator

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

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 10, 2019
• Study Start: August 19, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 26, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)