Breastmilk as a Source of Lactocytes

Micronutrients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05857345
• Other study ID #: Breastmilk
• Status: Completed
• Start date: April 28, 2023
• Est. completion date: October 23, 2023

Study information

• Verified date: November 2023
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 23, 2023
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breastmilk Collection
• Micronutrients

Intervention

Other:
• Collection of breastmilk
Collection of breastmilk and other information about the participant

Locations

Country	Name	City	State
Germany	University of Hohenheim	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
University of Hohenheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Micronutrient Content	Micronutrient content of breastmilk will be analyzed and whether changes occur over time	6 month after completion