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Breastmilk as a Source of Lactocytes

Assessing Gene Expression in Lactocytes Using Human Breast Milk as a Non-Invasive Source: A Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05857345
Enrollment
10
Registered
2023-05-12
Start date
2023-04-28
Completion date
2023-10-23
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastmilk Collection, Micronutrients

Brief summary

The objective of this study is to determine the suitability of lactocytes derived from human breast milk for gene expression analysis, and to explore whether there are any correlations between gene expression and the micronutrient composition of breast milk.

Detailed description

Participants will be included in the study if they are willing to express milk and if their child is between 2 weeks and 6 months old. Participants' feeding practices (exclusive breastfeeding/non-exclusive breastfeeding) and micronutrient supplementation will be recorded. On the day of donation, child's age, the health status of both the mother and child (sick/not sick), the time of sample collection, and the number of feeding sessions that have taken place since midnight will be recorded.

Interventions

OTHERCollection of breastmilk

Collection of breastmilk and other information about the participant

Sponsors

University of Hohenheim
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Willingness to express breastmilk * Breastfed infant aged between 2 weeks and 6 months

Exclusion criteria

* Not willing to express breastmilk * Infant older or younger than specified

Design outcomes

Primary

MeasureTime frameDescription
Gene Expression6 month after completionGene expression of cellular markers from various cell populations in breast milk, as well as expression of proteins involved in micronutrient transport will be investigated. Additionally, these gene expression patterns will be investigated over time.
Micronutrient Content6 month after completionMicronutrient content of breastmilk will be analyzed and whether changes occur over time

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026