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CompletedNCT05857345Updated Nov 28, 2023

Breastmilk as a Source of Lactocytes

An observational study in Breastmilk Collection and Micronutrients, sponsored by University of Hohenheim. Completed at 1 site in Germany. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by University of Hohenheim · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
10
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breastmilk Collection
  • Micronutrients

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03

In context

Breast Milk Expression

88 studies on the registry are indexed under Breast Milk Expression; 20 are open to participants now.

This study's enrollment of 10 is below the median of 71 across 36 observational studies indexed under Breast Milk Expression.

Browse Breast Milk Expression studies →

Lead sponsor

University of Hohenheim is the lead sponsor of 43 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Lactating mothers in Germany

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Not willing to express breastmilk
  • Infant older or younger than specified
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
10 participants (actual)
Patient registry
No

Groups and cohorts

  • Lactating individuals

    Lactating adults (age \>= 18) with children aged 2 weeks to 6 month

    Other: Collection of breastmilk

Interventions

  • OtherCollection of breastmilk

    Collection of breastmilk and other information about the participant

06

What researchers measure

Primary outcomes

  1. Gene Expression

    Gene 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.

    Time frame: 6 month after completion

  2. Micronutrient Content

    Micronutrient content of breastmilk will be analyzed and whether changes occur over time

    Time frame: 6 month after completion

07

Study locations

1 site
  • University of Hohenheim
    Stuttgart, 70593, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05857345
Lead sponsor
University of Hohenheim
Responsible party
Sponsor
First posted
May 12, 2023
Start date
Apr 28, 2023
Primary completion
Oct 23, 2023
Completion
Oct 23, 2023
Last update
Nov 28, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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