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Probiotics effective against preterm delivery

Randomised controlled trial, pilot study: changing vaginal microflora of pregnant women by oral probiotics

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN40042090
Enrollment
320
Registered
2010-11-04
Start date
2010-10-04
Completion date
Unknown
Last updated
2019-02-11

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

Conditions

Pregnant women with abnormal vaginal flora Pregnancy and Childbirth Other inflammation of vagina and vulva

Interventions

1. Experimental Group: Daily oral intake of one capsule containing Lactobacillus rhamnosus GR-1 (GR-1®) and Lactobacillus reuteri RC-14 (RC-14®). The dosage at end-of-shelf-life is 1 × 109 colony form

Sponsors

University Children's Hospital Tübingen (Germany)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Pregnant women, resident within the study area at the time of enrolment and being attending a medical practice located within the study area (A random selection process will assure representativeness of recruiting practices and, hence, external validity) 2. Over 18 years 3. Less than 12 completed weeks of pregnancy (WOP) 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Active chronic inflammatory bowel disease (M. Crohn, Colitis ulcerosa) 2. Immunodeficiency

Design outcomes

Primary

MeasureTime frame
Restoration from asymptomatic pathologic vaginal flora to a normal lactobacilli colonisation and an increase in lactobacilli in the vaginal flora after 8 weeks of intervention.

Countries

Germany

Outcome results

None listed

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