NCT05857345

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

April 28, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

April 21, 2023

Last Update Submit

November 27, 2023

Conditions

Breastmilk CollectionMicronutrients

Outcome Measures

Primary Outcomes (2)

  • 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.

    6 month after completion

  • Micronutrient Content

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

    6 month after completion

Study Arms (1)

Lactating individuals

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

Other: Collection of breastmilk

Interventions

Collection of breastmilkOTHER

Collection of breastmilk and other information about the participant

Lactating individuals

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsYes
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lactating mothers in Germany

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hohenheim

Stuttgart, 70593, Germany

Location

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast FeedingFeeding BehaviorBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2023

First Posted

May 12, 2023

Study Start

April 28, 2023

Primary Completion

October 23, 2023

Study Completion

October 23, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)