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OpenTrials
Completed

NCT Number: NCT05857345

Breastmilk as a Source of Lactocytes

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Hohenheim

Stuttgart, 70593, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of breastmilk

Other

Collection of breastmilk and other information about the participant

Primary outcomes

  1. 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.

  2. Micronutrient Content

    Time frame: 6 month after completion

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

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 12, 2023
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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