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

University of Wisconsin (UW)

Status: Enrolling

Conditions: Human Milk

Treatments: Device: Remote Human Milk Sample Collection

Study type: Interventional

Funder types: Other

Identifiers

NCT07118852

Pending

2025-0663

Protocol Version 11/11/25 (Other Identifier)

NUR/FACULTY AFFAIRS/ADMIN (Other Identifier)

Details and patient eligibility

About

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.

Full description

To preserve the quality of RNAs, commonly used methods for collecting fresh human milk samples typically require a stringent collection and handling routine. This includes proximity to a laboratory (within 20 minutes of driving distance) and ultra-cold storage conditions (below -80°C). Compared to "non-research" settings, current standards in sample collection require either 1) participant travel or 2) home visits for biospecimen collection. These requirements impede the inclusion of wide, non- biased milk samples from a range of populations, which is necessary for robust human subject studies. Subsequently, certain populations are excluded due to arbitrary factors like location, daytime availability, and residence. The development of human milk collection protocols that enable wide-ranging participation is a research priority that supports our research at the University of Wisconsin - Madison and any global investigative efforts that include human milk RNA sequencing.

Recruitment will take place in 2 phases (N=25 participants each) to allow for adjustments to the biospecimen collection kit and optimization of RNA integrity. During the first recruitment phase, N=25 participants will be recruited and enrolled using a reagent: human milk concentration of approximately 2:1.

After return of N=25 participant kits, recruitment will briefly pause to extract RNA and run RNA integrity analyses. Results of analyses will inform whether to proceed to phase 2 (recruitment and enrollment of an additional N=25 participants) with the same reagent: human milk concentrations or whether to adjust volume or concentration. Total volume of human milk collection will not exceed 30 mL.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• English speaking and reading
• Lactating for greater than or equal to 4 weeks

Exclusion criteria

• not meeting personal lactation goals
• resides outside of Wisconsin

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Lactating Participants

Experimental group

Treatment:

Device: Remote Human Milk Sample Collection