Probiotics effective against preterm delivery
| ISRCTN | ISRCTN40042090 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40042090 |
| Secondary identifying numbers | 1.1 |
- Submission date
- 27/09/2010
- Registration date
- 04/11/2010
- Last edited
- 18/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Scientific
Department of Neonatology
Calwerstrasse 7
Tuebingen
72076
Germany
| Phone | +49 (0)7071 2984742 |
|---|---|
| christian-f.poets@med.uni-tuebingen.de |
Study information
| Study design | Randomised triple-blind placebo-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Randomised controlled trial, pilot study: changing vaginal microflora of pregnant women by oral probiotics |
| Study acronym | EFFPRO-Pilot |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 04/10/2010 |
| Completion date | 04/02/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 320 |
| Key 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 |
| Key exclusion criteria | 1. Active chronic inflammatory bowel disease (M. Crohn, Colitis ulcerosa) 2. Immunodeficiency |
| Date of first enrolment | 04/10/2010 |
| Date of final enrolment | 31/05/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
72076
Germany
Sponsor information
Hospital/treatment centre
c/o Prof. Dr. Christian F. Poets
Department of Neonatology
Calwerstrasse 7
Tuebingen
72076
Germany
"ROR" |
https://ror.org/03esvmb28 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Results of the study will be published in international journals |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2016 | 18/01/2019 | Yes | No |
Editorial Notes
18/01/2019: Publication reference added
