Breastmilk as a Source of Lactocytes

Sponsor

University of Hohenheim (Other)

Overall Status

Recruiting

CT.gov ID

NCT05857345

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breastmilk Collection Micronutrients	Other: Collection of breastmilk

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 Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Sep 29, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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.
Micronutrient Content [6 month after completion]
Micronutrient content of breastmilk will be analyzed and whether changes occur over time

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Hohenheim	Stuttgart		Germany	70593

Sponsors and Collaborators

University of Hohenheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Hohenheim

ClinicalTrials.gov Identifier:

NCT05857345

Other Study ID Numbers:

Breastmilk

First Posted:

May 12, 2023

Last Update Posted:

May 16, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 16, 2023