Safety and efficacy of putative vaginal probiotics in healthy women
| ISRCTN | ISRCTN17618579 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17618579 |
| Secondary identifying numbers | 244/T-14 |
- 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
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
Scientific
Tiigi 61b
Tartu
50410
Estonia
| Phone | +372 7374 178 |
|---|---|
| reet.mandar@ut.ee |
Study information
| Study design | Randomised, double blind, placebo controlled crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a patient 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 | 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 study start date | 01/02/2015 |
| Completion date | 31/08/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 50 persons, 10 subjects in each arm |
| 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
Tartu
50410
Estonia
Sponsor information
Research organisation
Tiigi 61b
Tartu
50410
Estonia
| Website | www.ccht.ee |
|---|---|
"ROR" |
https://ror.org/05kagrs11 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| 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) |
| IPD sharing plan |
Editorial Notes
22/05/2019: The sponsor and funder contact details were updated.
