Condition category
Pregnancy and Childbirth
Date applied
27/09/2010
Date assigned
04/11/2010
Last edited
30/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

University Children's Hospital Tübingen (Germany)

Sponsor details

c/o Prof. Dr. Christian F. Poets
Department of Neonatology
Calwerstrasse 7
Tuebingen
72076
Germany

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes