Plain English Summary
Background and study aims
Preterm delivery (i.e., giving birth before 37 weeks of pregnancy) is a leading cause of illness and death in newborn babies. It often results from infections caused by changes in the vaginal microbiota - the microorganisms found in the vagina. Probiotics are live microorganisms that may be able to help prevent and treat some illnesses. Probiotics were found to be effective at treating vaginal infections in non-pregnant women, but there have been no studies in pregnant women. The aim of this study is to find out the effects of taking a commercially available probiotic tablet in routine antenatal care.
Who can participate?
Pregnant women aged over 18 years at less than 12 completed weeks of pregnancy.
What does the study involve?
Participants are randomly allocated to one of two groups. One group takes one probiotic capsule every day for 8 weeks. The other group takes a placebo (dummy) capsule every day for 8 weeks. Two vaginal swabs are taken before and after the treatment to assess the vaginal microbiota, and participants complete questionnaires over the telephone.
What are the possible benefits and risks of participating?
Probiotics have already been used during pregnancy and seem to be safe. The possible benefits are positive effects on the vaginal microbiota which may act against infections.
Where is the study run from?
University Children's Hospital Tübingen (Germany).
When is the study starting and how long is it expected to run for?
October 2010 to May 2012.
Who is funding the study?
University Children's Hospital Tübingen (Germany).
Who is the main contact?
Prof Christian F Poets
christian-f.poets@med.uni-tuebingen.de
Trial website
Contact information
Type
Scientific
Primary contact
Prof Christian F Poets
ORCID ID
Contact details
Department of Neonatology
Calwerstrasse 7
Tuebingen
72076
Germany
+49 (0)7071 2984742
christian-f.poets@med.uni-tuebingen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.1
Study information
Scientific title
Randomised controlled trial, pilot study: changing vaginal microflora of pregnant women by oral probiotics
Acronym
EFFPRO-Pilot
Study hypothesis
Daily oral intake of probiotic lactobacilli strains (L. rhamnousus GR-1 and L. fermentum RC-14) will lead to a reduction of pathologic vaginal microflora and increased number of lactobacilli in the vaginal flora. We aim to demonstrate that an intervention delivered via the public health care system is effective and well accepted by pregnant women.
On 30/09/2015 the following changes were made to the trial record:
1. The overall trial end date was changed from 04/02/2011 to 04/02/2013.
2. The target number of participants was changed from 60 to 320.
Ethics approval
1. The Ethics Committee of the Medical Faculty of the University of Tuebingen, 02/07/2010, ref: 238/1010B01
2. An amendment of the study protocol was approved on 24/11/2010
Study design
Randomised triple-blind placebo-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Pregnant women with abnormal vaginal flora
Intervention
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 forming units of each strain per capsule. The intake will last for 8 weeks, starting individually after the participants first routine antenatal visit after enrolment. Both, verum and placebo will be provided by Chr. Hansen A/S (DK-2970 Hørsholm, Denmark). The verum product is licensed and sold as a food supplement in Europe (Probio-Tec® UREX-cap-5), including Germany (Femibion® Flor Intim).
2. Control group: Daily oral intake of one capsule placebo. The intake will start and end according to the intervention group. Verum and placebo will be provided in identical packing by the drug manufacturer. Placebo capsules will be similar to probiotic capsules and will not be distinguishable from verum, neither by visual inspection nor by taste.
Intervention type
Other
Phase
Phase IV
Drug names
Primary outcome measure
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.
Secondary outcome measures
None
Overall trial start date
04/10/2010
Overall trial end date
04/02/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
320
Participant exclusion criteria
1. Active chronic inflammatory bowel disease (M. Crohn, Colitis ulcerosa)
2. Immunodeficiency
Recruitment start date
04/10/2010
Recruitment end date
31/05/2012
Locations
Countries of recruitment
Germany
Trial participating centre
University Children's Hospital Tübingen
Tuebingen
72076
Germany
Funders
Funder type
Hospital/treatment centre
Funder name
University Children's Hospital Tübingen (Germany) - Department of Neonatology, internal funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
There is no co-financing by industry and/or other third parties. However, study drugs will be provided for a small fee by Chr. Hansen, Denmark.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results of the study will be published in international journals
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
1. 2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27342046 (added 18/01/2019)