Condition category
Not Applicable
Date applied
11/03/2015
Date assigned
16/04/2015
Last edited
16/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

ClinicalTrials.gov number

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 measures

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

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

Competence Centre on Health Technologies

Sponsor details

Tiigi 61b
Tartu
50410
Estonia

Sponsor type

Research organisation

Website

http://ccrmb.ee/

Funders

Funder type

Not defined

Funder name

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes