Condition category
Infections and Infestations
Date applied
04/10/2016
Date assigned
13/02/2017
Last edited
13/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Phase

Drug names

Primary outcome measures

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

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

Competence Centre on Health Technologies

Sponsor details

Tiigi 61b
Tartu
50410
Estonia
+372 733 0401
ccht@ccht.ee

Sponsor type

Other

Website

www.ccht.ee

Funders

Funder type

Other

Funder name

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes