Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Reet Mändar
ORCID ID
Contact details
Tiigi 61b
Tartu
50410
Estonia
+372 7374 178
reet.mandar@ut.ee
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
244/T-14
Study information
Scientific title
Safety and efficacy of potential vaginal probiotics administrated orally in healthy volunteers
Acronym
CRI
Study hypothesis
The consumption of a dietary supplement containing Lactobacillus crispatus strains is safe and helps to improve vaginal and gastrointestinal microbiota
Ethics approval
Ethics Review Committee on Human Research of the University of Tartu, 19/01/2015, ref: 244/T-14
Study design
Randomised, double blind, placebo controlled crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet.
Condition
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
Phase
Drug names
Primary outcome measure
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
Secondary outcome measures
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
Overall trial start date
01/02/2015
Overall trial end date
31/08/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Healthy volunteer
Age group
Adult
Gender
Female
Target number of participants
50 persons, 10 subjects in each arm
Participant 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
Recruitment start date
01/03/2015
Recruitment end date
31/05/2015
Locations
Countries of recruitment
Estonia
Trial participating centre
Competence Centre on Health Technologies
Tiigi 61b
Tartu
50410
Estonia
Sponsor information
Organisation
Tervisetehnoloogiate Arenduskeskus AS (Competence Centre on Health Technologies)
Sponsor details
Tiigi 61b
Tartu
50410
Estonia
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
1. Presentation of results at 9th Probiotics, Prebiotics, New Foods in September 2017, Rome (Italy)
2. Publication after December 2016 (e.g., in Applied Biochemistry and Microbiology, Beneficial Microbes, Journal of Applied Microbiology)
Intention to publish date
31/12/2016
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list