Human MilkNCT07118852
Developing Remote Human Milk Collection as a Novel Technique for Transcriptome Sequencing
A study testing Remote Human Milk Sample Collection in people with Human Milk, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Milk
- What is being tested?
- Remote Human Milk Sample Collection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2025to 4 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking and reading
- Lactating for greater than or equal to 4 weeks
Who cannot join
- not meeting personal lactation goals
- resides outside of Wisconsin
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Remote Human Milk Sample Collection
- Keywords
- sample collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Human Milk Sample CollectionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Lactating Participants | Experimental | Not described Receives: Device: Remote Human Milk Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, anticipated to be 1 year
Secondary outcomes (5)
Concentration of RNA in Human Milk
The concentration of extracted RNA (ng/uL) will be measured by a Qubit Fluorometer.
Measured: through study completion, anticipated to be 1 year
Purity of RNA in Human Milk
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.
Measured: through study completion, anticipated to be 1 year
RNA Integrity Number (RIN)
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.
Measured: through study completion, anticipated to be 1 year
Quantitative PCR (qPCR)
The epithelial cell and microRNA population will be quantified by measuring expression of epithelial cell and microRNA target genes.
Measured: through study completion, anticipated to be 1 year
Sample Collection Feasibility Data
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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start14 Nov 2025
- Primary completion4 May 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human MilkStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katelyn Desorcy-Scherer, PhD, RN, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118852
- Sponsor's protocol ID
- 2025-0663
- Other IDs
- Pending, Protocol Version 5/7/26, NUR/FACULTY AFFAIRS/ADMIN
- Status last verified
- Jun 2026
- First submitted
- 5 Aug 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Remote Human Milk Collection as a Novel Technique for Transcriptome Sequencing
- ClinicalTrials.gov ID
- NCT07118852
- Acronym / sponsor ID
- 2025-0663
- Conditions
- Human Milk
- Keywords
- sample collection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactating Participants | Experimental | Device: Remote Human Milk Sample Collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English speaking and reading
- Lactating for greater than or equal to 4 weeks
Key exclusion criteria (2 listed)
- not meeting personal lactation goals
- resides outside of Wisconsin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Human Milk Sample CollectionTwo 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. | Device | Lactating Participants |
Primary outcome
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.
5 secondary outcomes
Concentration of RNA in Human Milk
Time frame: through study completion, anticipated to be 1 year
Purity of RNA in Human Milk
Time frame: through study completion, anticipated to be 1 year
RNA Integrity Number (RIN)
Time frame: through study completion, anticipated to be 1 year
Quantitative PCR (qPCR)
Time frame: through study completion, anticipated to be 1 year
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katelyn Desorcy-Scherer, PhD, RN principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Human Milk Sample Collection in people with Human Milk, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Development of a Remote Collection Protocol reported as the final Reagent:Sample ratio (time frame: through study completion, anticipated to be 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.