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NCT01959113 · ClinicalTrials.gov registry record · Phase 1
Validation of the Short-term Antimicrobial Action of Transplanted Bacteria
A Phase 1 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01959113 is a Phase 1 study that has completed, run by University of California, San Diego. The registered enrollment target is 5 participants.
The verdict
NCT01959113, a Phase 1 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of S. aureus skin infections. In addition, research in the investigator's lab has shown that these patients have fewer protective antimicrobial Staphylococcal species such as Staphylococcal epidermidis (S. epidermidis) that are known to produce antimicrobial peptides that play a role in protecting the skin from invading pathogens. In this study, the investigator will attempt to decrease S. aureus colonization and increase colonization by protective Staph species in AD patients. First the investigator will capture the bacteria on subjects' lesional AD skin. Next the investigator will selectively grow the subject's antimicrobial Staphylococcal colonies and place them into a base moisturizer. The moisturizer plus bacteria will be applied to one of the subject's arms, and the moisturizer alone (without bacteria) to the other arm. The investigator will then do a quantitative wash of the bacteria growing on each arm one day later in order to determine whether the S. aureus abundance was affected by the application of the transplanted bacteria.
Interventions
- BIOLOGICAL Autologous Microbiome Transplant
- OTHER Placebo Arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01959113
The ClinicalTrials.gov registry entry for NCT01959113 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Autologous Microbiome Transplant is the first listed.
NCT01959113 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01959113 about?
NCT01959113 is a clinical study titled "Validation of the Short-term Antimicrobial Action of Transplanted Bacteria". Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of S. aureus skin infections. In addition, research in the investigator's lab has shown that these patients have fewer ...
What is the current status of trial NCT01959113?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2015-01. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01959113?
The interventions under investigation include: Autologous Microbiome Transplant (BIOLOGICAL), Placebo Arm (OTHER).
Who is sponsoring clinical trial NCT01959113?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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