Clinical trial NCT05797818: Red Light Photobiomodulation and Topical Disinfectants
Official title: The Effect of Red Light Photobiomodulation and Topical Disinfectants on the Nasal Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthcare Associated Infection
Nosocomial Infection
Surgical Site Infection
Keywords: Staphylococcal aureus
Methylene blue
Chlorhexidine gluconate
Nasal decolonization
Photobiomodulation
Photodynamic therapy
Nasal microbiome
Lead sponsor: Ondine Biomedical Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A single open-label healthy group is being evaluated for any changes to the normal nasal microbiome. Each week nasal cultures will be done and the subject exposed to different interventions including red light alone, and several disinfectants. Nasal cultures will be done for 48 hours after the intervention to determine the effect, if any, on the nasal microbiome.
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to evaluate the potential effects of photobiomodulation when used with topical disinfectants in the anterior nares of healthy adults.

Over a three week period, participants will have their anterior nares swabbed with methylene blue, chlorhexidine gluconate, or a combination of the two followed by 4 minutes of non-thermal red light treatment. The fourth week of consist of only red light treatment. Culture samples of the subjects nasal microbiome will be taken prior to treatment, immediately after treatment, 4-, 8-, 24-, and 48 hours after treatment.

Detailed description: This is an exploratory, single-center, open-label, single-arm study with microbiological endpoint using photobiomodulation (PBM) and topical disinfectants to determine the effect on the nasal microbiota.

The photobiomodulation system distributes about 700mW of light to each nostril using a 2-channel diode laser with non-thermal, red light. The topical disinfectants are methylene blue (0.01%) and chlorhexidine gluconate (0.25%). Following a pretreatment nasal culture, these two disinfectants will be administered into the patient's anterior nares followed by a two-minute light cycle. This process is repeated once more resulting in two treatments cycles (4-minutes total). Following this, nasal cultures are taken immediately and at 4-, 8-, 24-, and 48- hours. Broad spectrum and Staphylococcus spp. culturing of nasal swabs will be conducted. Swabs will also be submitted for Next Generation Sequencing to characterize the effect of light and disinfectants on the nasal microbiome.

Eligibility criteria: Inclusion Criteria:

* Subjects must be 18 years of age or older

Exclusion Criteria:

* Pregnant Women
* Those Under 18 years of age
* Prisoners
* Mentally Disabled Persons

Primary outcomes:
measure: Effect of PBM with Topical Disinfectants (Quantitative)
timeFrame: The change in bacterial bioburden during the week of each of the four weeks respective intervention.
measure: Effect of PBM with Topical Disinfectants (Semi-Quantitative)
timeFrame: The change in bacterial bioburden during the week of each of the four weeks respective intervention.
Secondary outcomes:
measure: Effect of PBM with Topical Disinfectants (NGS)
timeFrame: The change in bacterial bioburden during the week of each of the four weeks respective intervention.
Other outcomes:
Locations:
city: Bothell
country: United States
facility: Ondine Research Laboratories
state: Washington
Study officials:
affiliation: Ondine Biomedical
name: ROGER ANDERSEN, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: