Probiotics Pilot Project

NCT ID: NCT04247854

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-12

Study Completion Date

2021-01-22

Brief Summary

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This pilot study is designed to determine if ingestion of Bacillus probiotics can cause alteration in levels of S. aureus colonization in the nose and intestine in preoperative orthopedic patients undergoing elective primary TJA.

Detailed Description

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Conditions

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Staphylococcus Aureus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotic

Group Type ACTIVE_COMPARATOR

Bacillus subtilis probiotic

Intervention Type DIETARY_SUPPLEMENT

Bacillus probiotic which contains one confidential ingredient of Bacillus subtilis spores (2 x 1010 CFU/g). Over 5 days of interventional period, the patient receives one tablet (250 mg; 5 x 109 CFU) of probiotic per day.

No intervention

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Over 5 days of interventional period, the patient receives 1 placebo tablet per day

Interventions

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Bacillus subtilis probiotic

Bacillus probiotic which contains one confidential ingredient of Bacillus subtilis spores (2 x 1010 CFU/g). Over 5 days of interventional period, the patient receives one tablet (250 mg; 5 x 109 CFU) of probiotic per day.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Over 5 days of interventional period, the patient receives 1 placebo tablet per day

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Adults (age \>18 years)
2. Undergoing elective primary knee or hip arthroplasty
3. Confirmed colonization of nares and/or rectum with S. aureus or MRSA on routine standard-of-care preadmission testing
4. Written informed consent

Exclusion Criteria

1. Regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment
2. Antibiotic use within 3 months prior to enrollment
3. Active clinical infection
4. Participation in other clinical trials
5. Presence of pregnancy or lactation
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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2020-01 JP

Identifier Type: -

Identifier Source: org_study_id

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