Developing Remote Human Milk Collection as a Novel Technique for Transcriptome Sequencing

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07118852
Status
Recruiting

Conditions

  • Human Milk

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Remote Human Milk Sample Collection — DEVICE
    Two products will be evaluated for their ability to preserve RNA in human milk samples. * RNAlater (ThermoFisher©) (ratio variable) * NucleoProtect RNA (Takara©) (ratio variable)\* * Product volume mixed with human milk samples will vary by product and may be titrated as part of protocol development.

Study Details

This study will develop a protocol for remote human milk collection for use in gene expression research through application of ribonucleic acid (RNA) preservation reagents. The investigators hypothesize that addition of preservation reagents will preserve RNA in human milk, facilitating downstream analyses that require intact RNA. 50 lactating participants will be recruited and requested to provide reagent-mixed samples to be sent to the university through shipping services where they will be evaluated for RNA quantity, quality and profile.

Key Dates

Start date
Nov 14, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Lactating Participants

Primary Outcome Measure

Successful Development of a Remote Collection Protocol reported as the final Reagent:Sample ratio [ Time Frame: through study completion, anticipated to be 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53705-

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