NCT07118852

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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. Total volume of human milk collection will not exceed 30 mL.

Conditions

• Human Milk

Interventions

Type	Name	Description
DEVICE	Remote Human Milk Sample Collection	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.

Timeline

• Start date: 2025-11-14
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-08-12
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study