Clinical Trial

Single-center Evaluation of Human Milk Quantity and Quality Over Five Years

Study acronym: HUMBLE
Recruiting
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Record status
This record was last updated March 18, 2026 (before its estimated May 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
This single-center retrospective observational study includes all human milk donors collaborating with the milk bank at České Budějovice Hospital between 2021 and 2025. Using anonymized data extracted from the hospital database, the study will quantify the frequency of donations and the individual and cumulative volume of donated human milk and will assess the impact of key maternal and perinatal factors - including age, BMI, parity, mode of delivery, and timing of donations - on the quantity and quality of donated milk, based on routine biochemical and microbiological parameters.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-15.
Status change: Not Yet Recruiting → Recruiting 2026-03-16
Trial Details
NCT Number NCT07309146
Lead Sponsor Charles University, Czech Republic
Collaborators: Nemocnice České Budějovice, České Budějovice, Czechia
Conditions Lactating Women - Human Milk Donors
Enrollment 500 participants
Start Date 2026-01-01
Primary Completion 2026-05-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-18