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Completed

NCT Number: NCT07118852

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

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.

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Key information

Conditions

Human Milk

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: through study completion, anticipated to be 1 year

    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.

Secondary outcomes

  1. Concentration of RNA in Human Milk

    Time frame: through study completion, anticipated to be 1 year

    The concentration of extracted RNA (ng/uL) will be measured by a Qubit Fluorometer.

  2. Purity of RNA in Human Milk

    Time frame: through study completion, anticipated to be 1 year

    The purity of extracted RNA will be measured by a Qubit Fluorometer. Purity will be assessed using wavelengths, the ratio of absorbance for A260/280 and A230/280.

  3. RNA Integrity Number (RIN)

    Time frame: through study completion, anticipated to be 1 year

    Integrity of the extracted RNA will be measured using an agilent bioanalyzer. RIN is reported on a scale of 1 to 10 where higher numbers indicate higher integrity.

  4. Quantitative PCR (qPCR)

    Time frame: through study completion, anticipated to be 1 year

    The epithelial cell and microRNA population will be quantified by measuring expression of epithelial cell and microRNA target genes.

  5. Sample Collection Feasibility Data

    Time frame: 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)

    Participants answer 8-items scored on a 1 (discourage) to 10 (encourage) scale regarding participation in lactation research to assess factors that would facilitate their participation (use of own breast pump, ability to use breast pump, opportunity to privately express a sample in a clinic or at home, handling reagents with gloves, opportunity to participate in maternal and infant health research, opportunity to participate in genetic research).

Other outcomes

  1. Perceived Stress Scale

    Time frame: 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)

    scored from 0-40 with higher scores indicating higher stress

  2. Generalized Anxiety Disorder (GAD-7)

    Time frame: 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)

    Scores range from 0 to 21, with higher scores indicating greater anxiety.

  3. Edinburgh Postpartum Depression Scale (EPDS)

    Time frame: 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)

    scored from 0-30 with higher scores indicating higher depression

  4. MEDQ-Sus Questionnaire

    Time frame: 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)

    scored from 0-16 with higher scores indicating greater adherence to a Mediterranean dietary pattern

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2025
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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