Supplementation of probiotics in pregancies with imminent preterm birth

Supplementation of probiotics in pregancies with imminent preterm birth - PROMO

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033539

Enrollment

145

Registered

2024-03-19

Start date

2024-03-20

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

imminent preterm birth, perterm delivery, perinatal infections, dysbiosis, mircobiome

Interventions

Group 1: Intake of probiotics/ Intervention One capsule per day of Bactiol Infantis (Bifidobacterium longum subsp. infantis, B. animalis subsp. lactis (BB-12) and Lactobacillus acidophilus (La-5)) unt

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: imminent preterm birth

Exclusion criteria

Exclusion criteria: primary weaning

Design outcomes

Primary

Measure	Time frame
Changes in composition of human milk oligosacchrides (HMO) in breast milk 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 nuclear magnetic resonance (NMR) spectroscopy at Institute of Chemistry and Metabolomics.	—

Secondary

Measure	Time frame
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.	—

Countries

Germany

Contacts

Public ContactAmrei Welp

Universitätsklinikum Schlwesig Holstein

amrei.welp@uksh.de+49 451 500 74989

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026