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

Reduction of Small Intestinal Ulceration Risk Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03910322
• Other study ID #: HND-GI-035
• Status: Terminated
• Phase: N/A
• Start date: August 19, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: August 2019
• Source: Chr Hansen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Reduction of Small Intestinal Ulceration Risk
• Ulcer

Intervention

Dietary Supplement:
• Bif195
Two different doses of the bacterial strain Bif195 is compared to placebo
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Atlantia Food Clinical Trials	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Chr Hansen	Atlantia Food Clinical Trials

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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