Safety and efficacy of putative vaginal probiotics in healthy women

ISRCTN	ISRCTN17618579
DOI	https://doi.org/10.1186/ISRCTN17618579
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	244/T-14
Sponsor	Tervisetehnoloogiate Arenduskeskus AS (Competence Centre on Health Technologies)
Funder	Tervisetehnoloogiate Arenduskeskus AS (Competence Centre on Health Technologies)

Submission date: 11/03/2015
Registration date: 16/04/2015
Last edited: 22/05/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Probiotics are beneficial microbes that survive gastrointestinal passage and may improve microbiota. Daily oral intake of probiotic Lactobacillus crispatus strains may increase number of lactobacilli in the gut and vaginal microbiota. The aim of the study is to assess safety and efficacy of orally administered Lactobacillus crispatus strains in healthy women.

Who can participate?
Healthy women between the age of 18 and 50.

What does the study involve?
Eligible participants are randomly allocated to one of four groups. They take either the probiotic or a placebo every day for a week. This is followed by a so-called “wash out” period where the participants resume their normal diet but don’t take any probiotics. After this wash out period is complete, participants who had taken the probiotic are now given the placebo for a further week and vice versa.

What are the possible benefits and risks of participating?
There are no expected risks in participating, except a small risk of bruising from giving the blood sample.

Where is the study run from?
Competence Centre on Health Technologies (Estonia)

When is the study starting and how long is it expected to run for?
March 2015 to August 2015.

Who is funding the study?
Competence Centre on Health Technologies ( Estonia)

Who is the main contact?
Professor Reet Mändar
reet.mandar@ut.ee

Contact information

Prof Reet Mändar
Scientific

Tiigi 61b
Tartu
50410
Estonia

Phone	+372 7374 178
Email	reet.mandar@ut.ee

Study information

Primary study design	Interventional
Study design	Randomised, double blind, placebo controlled crossover trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Safety and efficacy of potential vaginal probiotics administrated orally in healthy volunteers
Study acronym	CRI
Study objectives	The consumption of a dietary supplement containing Lactobacillus crispatus strains is safe and helps to improve vaginal and gastrointestinal microbiota
Ethics approval(s)	Ethics Review Committee on Human Research of the University of Tartu, 19/01/2015, ref: 244/T-14
Health condition(s) or problem(s) studied	Healthy female
Intervention	1. Healthy volunteers will be randomly allocated according to a random number table to one of four groups and will take one capsule per day for 1 week followed by 2 weeks of washout, another 1 week capsules consumption followed by 2 weeks of washout: 1.1. A capsule containing five different Lactobacillus crispatus strains: each of strain in dose 1x10^9 colony forming units (370 mg) 1.2. Control: placebo product in capsulated form containing sucrose 2. Bodyweight will be measured 3. Participants will be asked to assess their wellbeing and gastrointestinal effects, and provide blood, self-collected vaginal swabs and faecal samples at every visit.
Intervention type	Supplement
Primary outcome measure(s)	1. To evaluate the safety and tolerability of consumption of probiotic capsules (5 different L. crispatus strains per capsule) 1.1. blood analysis (C-reactive protein, liver and renal function indices) 1.2. The self-reported questionnaire is applied containing questions on well-being, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, stool frequency) and changes in discharge
Key secondary outcome measure(s)	1. Change in total Lactobacillus counts in faecal and vaginal samples 2. Gastrointestinal and vaginal colonization of ingested L. crispatus strains 3. Change in Nugent score level
Completion date	31/08/2015

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	50
Key inclusion criteria	1. Desire to participate 2. Age 18–50 years 3. Signed informed consent 4. Participants considered themselves 'healthy' 5. Screening blood tests (blood glucose, glycated haemoglobin, inflammatory indices, liver and kidney functional tests)
Key exclusion criteria	1. Diabetes and acute infection 2. Food allergy 3. Use of any antimicrobial drug within past month 4. Current use of any regular concomitant medication, including medical preparations, non-steroidal anti-inflammatory drugs and antioxidant vitamins 5. Pregnancy or breastfeeding 6. History or clinical signs of cardiovascular abnormalities
Date of first enrolment	01/03/2015
Date of final enrolment	31/05/2015

Locations

Countries of recruitment

Estonia

Study participating centre

Competence Centre on Health Technologies

Tiigi 61b
Tartu
50410
Estonia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

22/05/2019: The sponsor and funder contact details were updated.