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

NCT07118852 | Recruiting FDA Device

• 4 other identifiers: 2025-0663PendingProtocol Version 2/4/26NUR/FACULTY AFFAIRS/ADMIN
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Milk

Keywords

sample collection

Outcome Measures

Primary Outcomes (1)

• Successful Development of a Remote Collection Protocol reported as the final Reagent:Sample ratio

  The primary endpoint is generation of a remote collection protocol for use with a leading reagent in RNA preservation of human milk. There is no statistical test or null hypothesis associated with this endpoint, rather, a summary of relevant findings from all study secondary and exploratory endpoints.

  through study completion, anticipated to be 1 year

Secondary Outcomes (5)

• Concentration of RNA in Human Milk

  through study completion, anticipated to be 1 year

• Purity of RNA in Human Milk

  through study completion, anticipated to be 1 year

• RNA Integrity Number (RIN)

  through study completion, anticipated to be 1 year

• Quantitative PCR (qPCR)

  through study completion, anticipated to be 1 year

• Sample Collection Feasibility Data

  data collected at time of sample return from participant (one time point greater than one month after lactation begins and within 7 days of sample collection)

Other Outcomes (4)

• Perceived Stress Scale

  data collected at time of sample return from participant (one time point greater than one month after lactation begins and within 7 days of sample collection)

• Generalized Anxiety Disorder (GAD-7)

  data collected at time of sample return from participant (one time point greater than one month after lactation begins and within 7 days of sample collection)

• Edinburgh Postpartum Depression Scale (EPDS)

  data collected at time of sample return from participant (one time point greater than one month after lactation begins and within 7 days of sample collection)

Study Arms (1)

Lactating Participants

EXPERIMENTAL

Device: Remote Human Milk Sample Collection

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.

Lactating Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• not meeting personal lactation goals
• resides outside of Wisconsin

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

Study Officials

• Katelyn Desorcy-Scherer, PhD, RN

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katelyn Desorcy-Scherer, PhD, RN

CONTACT

608-265-7485; desorcy@wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)