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

NCT ID: NCT07118852

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-14
• Study Completion Date: 2026-06-30

Brief 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.

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.

Conditions

Human Milk

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Lactating Participants

Group Type: EXPERIMENTAL

Remote Human Milk Sample Collection

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katelyn Desorcy-Scherer, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

UW School of Medicine and Public Health

Locations

University of Wisconsin

Madison, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Katelyn Desorcy-Scherer, PhD, RN

Role: CONTACT

desorcy@wisc.edu

608-265-7485

Other Identifiers

Protocol Version 11/11/25

Identifier Type: OTHER

Identifier Source: secondary_id

NUR/FACULTY AFFAIRS/ADMIN

Identifier Type: OTHER

Identifier Source: secondary_id

Pending

Identifier Type: REGISTRY

Identifier Source: secondary_id

2025-0663

Identifier Type: -

Identifier Source: org_study_id