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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: Completed Phase 1 study, sponsored by University of California, San Diego.

NCT01959113 is a Phase 1 study that has completed, run by University of California, San Diego. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The technique of quantitative washes will be used to determine the Staphylococcus aureus abundance on an area of lesional AD skin on the subject's forearm as a ratio of baseline S. aureus abundance

Interventions

  • BIOLOGICAL Autologous Microbiome Transplant
  • OTHER Placebo Arm

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2015-01
Est. Completion 2016-06
Phase Phase 1
University of California, San Diego

775 total trials

What the finished NCT01959113 record still lists

NCT01959113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which Autologous Microbiome Transplant is the first listed.

NCT01959113 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01959113's enrollment target sits among peer trials

5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01959113, the US trial registry maintained by the National Library of Medicine. NCT01959113 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.