NCT04247854

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

February 12, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

12 months

First QC Date

January 28, 2020

Last Update Submit

February 18, 2020

Conditions

Staphylococcus Aureus

Outcome Measures

Primary Outcomes (1)

  • Persistent Staphylococcus aureus colonization

    post-intervention: following 5 days of dietary supplementation

Secondary Outcomes (1)

  • Changes in microbiome composition

    post-intervention: following 5 days of dietary supplementation

Study Arms (2)

Probiotic

ACTIVE COMPARATOR
Dietary Supplement: Bacillus subtilis probiotic

No intervention

PLACEBO COMPARATOR
Other: Placebo

Interventions

Bacillus subtilis probioticDIETARY_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.

Probiotic
PlaceboOTHER

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

No intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment
  • Antibiotic use within 3 months prior to enrollment
  • Active clinical infection
  • Participation in other clinical trials
  • Presence of pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2020

First Posted

January 30, 2020

Study Start

February 12, 2020

Primary Completion

January 22, 2021

Study Completion

January 22, 2021

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

US(1)