MedPath

Supplementation of probiotics in pregancies with imminent preterm birth

Phase 2
Recruiting
Conditions
imminent preterm birth, perterm delivery, perinatal infections, dysbiosis, mircobiome
Registration Number
DRKS00033539
Lead Sponsor
niversitätsklinikum Schlwesig Holstein
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
145
Inclusion Criteria

imminent preterm birth

Exclusion Criteria

primary weaning

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes in composition of human milk oligosacchrides (HMO) in breast milk<br>based on samples of human milk from day 1,2,3 and day 7,14 and day 28 after birth . Samples will be stored at -80°C and analyzed with<br>nuclear magnetic resonance (NMR) spectroscopy at Institute of Chemistry and Metabolomics.
Secondary Outcome Measures
NameTimeMethod
Changes in maternal vaginal mircobiome and gastrointestinal microbiome of preterm infant will be analyzed with 16sRNS sequencing based on stool samples collected at day 1,2,3 and day 7,14 and day 28. Sequencing will be performed using MiSeq® platform (Illumina®, San Diego, California, USA) and MiSeq® reagent Kit V3 for 600 cycles.
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