Plain English Summary
Background and study aims
Many women will experience a vaginal infection at some point in their lives (vaginitis). The two most common types of vaginitis are caused by vaginal candidiasis (yeast infection, more commonly known as thrush) and bacterial vaginosis (overgrowth of uncommon bacteria in the vagina). Both of these conditions are thought to be caused by an imbalance in the normal bacteria that live in the vagina. Probiotics are live bacteria that are thought to be beneficial for health, possibly by increasing “good” bacteria (that doesn’t damage health) and reducing “bad” bacteria (that is potentially harmful) in the digestive system (gut). They are safe and cheap and most often used as food supplements. The aim of this study is to find out whether probiotics are a safe and effective treatment for bacterial vagionosis and vaginal candidiasis.
Who can participate?
Women aged between 18 and 50 who suffer from repeated bacterial vagionosis or vaginal candidiasis.
What does the study involve?
Participants are divided into two groups, depending on the condition they are suffering from (bacterial vagionosis or vaginal candidiasis). In each group, participants are randomly allocated to one of three groups who each receive different treatments. Those in the first group receive a probiotic combination nr II oral (by mouth) capsule, those in the second group receive a probiotic combination nr II vaginal capsule and those in the third group receive a placebo (dummy drug) to take by mouth. In all groups, participants are treated daily for 20 day periods over three months. To evaluate patient’s safety all the study participants are asked to fill-up special questionnaire about their well-being and different gastrointestinal and vaginal discharge symptoms during the whole study period, and asked to give blood and vaginal samples, taken by nurse or gynecologist at the clinic and self-collected vaginal swabs.
What are the possible benefits and risks of participating?
Participants benefit from receiving more information about their health than they would usually expect. There is a small risk of bruising, bleeding and discomfort during blood testing.
Where is the study run from?
Medita Clinic (Estonia)
When is the study starting and how long is it expected to run for?
April 2016 to December 2019
Who is funding the study?
Competence Centre on Health Technologies (Estonia))
Who is the main contact?
Professor Reet Mändar
reet.mandar@ut.ee
Trial website
Contact information
Type
Scientific
Primary contact
Prof Reet Mändar
ORCID ID
Contact details
Competence Centre on Health Technologies
Tiigi 61b
Tartu
50410
Estonia
+372 733 0401
reet.mandar@ut.ee
Additional identifiers
EudraCT number
2016-003638-25
ClinicalTrials.gov number
Protocol/serial number
CRI-BV/CRI-VC
Study information
Scientific title
Clinical and microbiological efficacy of novel probiotics in vaginitis
Acronym
CRI-BV/CRI-VC
Study hypothesis
The combination of Lactobacillus crispatus strains are safe and may relieve bacterial vaginosis and vaginal candidiasis symptoms and decreasing bacterial vaginosis and vaginal candidiasis recurrent episodes.
Ethics approval
Ethics Review Committee on Human Research of the University of Tartu, 19/01/2015, ref: 256/T-13
Study design
Randomised double blind placebo controlled parallel trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Vaginitis
Intervention
This study consists of two sub-studies in which participants are bacterial vaginosis (CRI-BV) or vaginal candidiasis (CRI-VC) patients.
Sub-study 1 - CRI-BV:
Participants will be randomly allocated according to a random number table to one of three groups.
Group 1: Participants receive a probiotic combination nr I oral capsule with dosages 3xe10 CFU per day
Group 2: Participants receive a probiotic combination nr I vaginal capsule with dosages 3xe10 CFU per day
Group 3: Participants receive a placebo oral capsule per day containing maltodextrin
Sub-study 2 - CRI-VC:
Participants will be randomly allocated according to a random number table to one of three groups.
Group 1: Participants receive a probiotic combination nr II oral capsule with dosages 3xe10 CFU per day
Group 2: Participants receive a probiotic combination nr II vaginal capsule with dosages 3xe10 CFU per day
Group 3: Participants receive a placebo oral capsule per day, containing maltodextrin
In both sub-studies, participants take all capsules together over 3 months, for 3 lots of 20 days. The follow-ups (study visits) take place after every 20 days capsule consumption. The wash-out period between the each treatment cycle is 7 days (during the menstruation time). At baseline, participants are asked to give vaginal swabs and blood samples. After the first two 20 day treatment cycle, participants attend study visits and are asked to bring self-collected vaginal swabs. After the final 20 day treatment cycle participants again provide vaginal swabs and blood samples.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
1.Safety and tolerability of consumption of probiotic capsules (3 different L. crispatus strains in vaginal capsules and 2 different L. crispatus strains in oral capsules) is assessed through:
1.1. Blood analysis (C-reactive protein, liver and renal function indices) taken by the gyneogologist at baseline and forth visit (90 days)
1.2 Microbiological culture and Amsel criteria testing by the gynecologist (vaginal swabs) at baseline visit
1.3 A questionnaire designed for the purpose of this study containing questions on wellbeing, habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, stool frequency) and changes in discharge at baseline, first, second and third visit (after 20, 40 and 60 days)
Secondary outcome measures
1. Total Lactobacillus counts are measured using cultures from faecal samples and vaginal swabs at baseline, after 20 days, 40 days, 60 days and 90 days
2. Gastrointestinal and vaginal colonization of ingested L. crispatus strains at baseline, after 20 days, 40 days, 60 days and 90 days
3. Total bacterial account (Lactobacillus, Gardnerella vaginalis, Mobiluncus) is measured by assessing Nugent score level at at baseline, after 20 days, 40 days, 60 days and 90 days
Overall trial start date
01/04/2016
Overall trial end date
31/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Sub-study 1 - CRI-BV
1. Female
2. Aged between 18 and 50 years
3. Recurrent bacterial vagionosis episodes (diagnosed with complaints and through Amsel criteria, confirmation with microscopy in 2 days)
Sub-study 2 - CRI-VC
1. Female
2. Aged between 18 and 50 years
3. Recurrent vaginal candidiasis episodes (diagnosed with complaints and clinical signs confirmation with culture testing in 2 days)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
200 persons in 6 parallel arms
Participant exclusion criteria
Sub-study 1 - CRI-BV
1. Pregnancy
2. Breat feeding
3. Aged under 18 years or over 50 years
4. Sexually transmitted infections
5. Diagnosis of vaginal candidiasis
Sub-study 2 - CRI-VC
1. Pregnancy
2. Breat feeding
3. Aged under 18 years or over 50 years
4. Sexually transmitted infections
5. Diagnosis of bacterial vaginosis
Recruitment start date
01/11/2016
Recruitment end date
01/12/2018
Locations
Countries of recruitment
Estonia
Trial participating centre
Medita Clinic
Teguri 37b
Tartu
50107
Estonia
Sponsor information
Organisation
Tervisetehnoloogiate Arenduskeskus AS (Competence Centre on Health Technologies)
Sponsor details
Tiigi 61b
Tartu
50410
Estonia
+372 733 0401
ccht@ccht.ee
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Tervisetehnoloogiate Arenduskeskus AS (Competence Centre on Health Technologies)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal such as Applied Biochemistry and Microbiology, Beneficial Microbes, or the Journal of Applied Microbiology.
IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/12/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list