Staphylococcus AureusNCT04247854
Probiotics Pilot Project
A study testing Bacillus subtilis probiotic in people with Staphylococcus Aureus, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Staphylococcus Aureus
- What is being tested?
- Bacillus subtilis probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to 22 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotic Bacillus for Decolonization of Methicillin-resistant Staphylococcus Aureus (MRSA) in Patients Undergoing Total Joint Arthroplasty: A Randomized, Prospective, Placebo-Controlled Pilot Study
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.
- Conditions
- Staphylococcus Aureus
- Being tested
- Bacillus subtilis probiotic, Placebo
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
Over 5 days of interventional period, the patient receives 1 placebo tablet per day
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Not described Receives: Dietary Supplement: Bacillus subtilis probiotic |
| No intervention | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent Staphylococcus aureus colonization
Measured: post-intervention: following 5 days of dietary supplementation
Secondary outcomes (1)
Changes in microbiome composition
as determine through next generation sequencing of samples collect from the patient
Measured: post-intervention: following 5 days of dietary supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start12 Feb 2020
- Primary completion22 Jan 2021 (estimated)
- Study completion22 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247854
- Sponsor's protocol ID
- 2020-01 JP
- Status last verified
- Feb 2020
- First submitted
- 28 Jan 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Bacillus for Decolonization of Methicillin-resistant Staphylococcus Aureus (MRSA) in Patients Undergoing Total Joint Arthroplasty: A Randomized, Prospective, Placebo-Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04247854
- Acronym / sponsor ID
- 2020-01 JP
- Conditions
- Staphylococcus Aureus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 22 Jan 2021 (estimated)
- Study completion
- 22 Jan 2021 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: Bacillus subtilis probiotic |
| No intervention | Placebo comparator | Other: Placebo |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacillus subtilis probioticBacillus 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. | Dietary supplement | Probiotic |
| PlaceboOver 5 days of interventional period, the patient receives 1 placebo tablet per day | Other | No intervention |
Primary outcome
Persistent Staphylococcus aureus colonization
Time frame: post-intervention: following 5 days of dietary supplementation
1 secondary outcome
Changes in microbiome composition
Time frame: post-intervention: following 5 days of dietary supplementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
Related trials for Staphylococcus Aureus
Not yet recruiting
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
HNSCC
RecruitingPhase 3
Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prosthetic Valve Endocarditis
Infective Endocarditis
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Active, not recruitingPhase 1
A Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adults
Staphylococcus Aureus Bloodstream Infection
Recruiting
Retention of Vernix Caseosa in Newborns for Primary Prevention of Atopic Dermatitis
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bacillus subtilis probiotic in people with Staphylococcus Aureus, run by Rothman Institute Orthopaedics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent Staphylococcus aureus colonization (time frame: post-intervention: following 5 days of dietary supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.