Breastmilk as a Source of Lactocytes

November 27, 2023 updated by: University of Hohenheim

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Stuttgart, Germany, 70593
        • University of Hohenheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Lactating mothers in Germany

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lactating individuals
Lactating adults (age >= 18) with children aged 2 weeks to 6 month
Other: Collection of breastmilk
Collection of breastmilk and other information about the participant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gene Expression
Time Frame: 6 month after completion
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.
6 month after completion
Micronutrient Content
Time Frame: 6 month after completion
Micronutrient content of breastmilk will be analyzed and whether changes occur over time
6 month after completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hohenheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2023

Primary Completion (Actual)

October 23, 2023

Study Completion (Actual)

October 23, 2023

Study Registration Dates

First Submitted

April 21, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Breastmilk

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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