Probiotics effective against preterm delivery

Phase 4

Completed

• Conditions: Pregnant women with abnormal vaginal flora; Pregnancy and Childbirth; Other inflammation of vagina and vulva

• Registration Number: ISRCTN40042090
• Lead Sponsor: niversity Children's Hospital Tübingen (Germany)

Brief Summary

1. 2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27342046 (added 18/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-04
• Study Completion: 2013-02-04
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 320

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.