Breastmilk as a Source of Lactocytes

Completed

• Conditions: Breastmilk Collection; Micronutrients
• Interventions: Other: Collection of breastmilk

• Registration Number: NCT05857345
• Lead Sponsor: University of Hohenheim

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.

Study Timeline

• Study First Submitted: 2023-04-21
• Study Start: 2023-04-28
• Study First Submitted QC: 2023-05-03
• Study First Posted: 2023-05-12
• Primary Completion: 2023-10-23
• Study Completion: 2023-10-23
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lactating individuals	Collection of breastmilk	Lactating adults (age \>= 18) with children aged 2 weeks to 6 month

Primary Outcome Measures

Name	Time	Method
Micronutrient Content	6 month after completion	Micronutrient content of breastmilk will be analyzed and whether changes occur over time
Gene Expression	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.

Trial Locations

Locations (1)

University of Hohenheim; 🇩🇪 Stuttgart, Germany