Plain English Summary
Background and study aims
Vaginal yeast infections are caused by a yeast called Candida, and symptoms include vaginal itching, burning, discharge, and pain with urination. The aim of this study is to find out whether PLANTAGYN, a probiotic food supplement, reduces the risk of the Candida infection coming back (relapse).
Who can participate?
Women aged over 18 with recurrent vaginal yeast infections (more than three relapses within 1 year)
What does the study involve?
Participants are randomly allocated to take either PLANTAGYN or placebo (dummy) oral capsules (one in the morning between meals) for 15 consecutive days, followed by 15 days without taking capsules, for 3 months. At the start of the study and after 45 and 90 days of treatment, the physician performs a clinical examination of the patient (itching, pain, burning, redness, swelling, discharge). Participants tell the clinician if a relapse of Candida infection occurs during the study, specifying the first day of appearance and any other events, including side effects.
What are the possible benefits and risks of participating?
PLANTAGYN may change the vaginal flora (bacteria), helping to keep it healthy and decreasing the occurrence of vaginal infections. No side effects are expected during the study as PLANTAGYN is a food supplement and is not known to cause side effects.
Where is the study run from?
Metropolitan Hospital (Romania)
When is the study starting and how long is it expected to run for?
May 2015 to May 2016
Who is funding the study?
Proge Farm Srl (Italy)
Who is the main contact?
Mr Nicu Trincu
Trial website
Additional identifiers
EudraCT number
2017-002827-97
ClinicalTrials.gov number
Protocol/serial number
PLANT_2015_RO
Study information
Scientific title
Activity and tolerability of L. plantarum P 17630, orally administered 5 x 10 9 CFU/capsule (PLANTAGYN) : a multicentre, double-blind, placebo-controlled study
Acronym
PLANTAGYN
Study hypothesis
Evaluation of the activity and tolerability of PLANTAGYN, a food supplement containing the probiotic strain Lactobacillus plantarum P 17630 5x109 (CFU/capsule), administrated orally which goes through the gastrointestinal tract, reaching and colonizing the vaginal epithelium and reducing the risk of relapses of Candida spp. The decrease of relapses will be evaluated as time intervals between relapses increases.
Ethics approval
The Ethics Committee of the University of Medicine & Pharmacy “Târgu Mureş”, Romania, 20/05/2015, ref: No.66
Study design
Multicentre double-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Vaginal candidosis
Intervention
The participants were assigned to a treatment sequence using a randomization list which is unknown to the Clinical Investigators and laboratory researchers. Half of the females were treated with PLANTAGYN and half with placebo.
1 capsule/day of PLANTAGYN/placebo, in the morning far from meals, for 15 consecutive days and 15 days of wash out. This administration was repeated for 3 consecutive months.
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
Lactobacillary grade (LBG) assessment of vaginal lactobacilli flora, assessed by microscopic vaginal swab examination at t0 (initial visit - baseline), t45 (after 45 days of treatment), t90 (after 90 days of treatment)
Secondary outcome measures
1. Genetic identification of the probiotic strain L. plantarum P17630 using PCR and the vaginal swabs collected during visits at t0 (initial visit - baseline), t45 (after 45 days of treatment), t90 (after 90 days of treatment)
2. Relapses of Candida spp; each patient communicated to the clinician if any relapses occurred during the 90-day follow-up
Overall trial start date
20/05/2015
Overall trial end date
16/05/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women with clinical history of recurrent yeast vaginitis (> 3 relapses within 1 year)
2. Age > 18 years
3. No foods with added probiotics (e.g. yogurts and derivate) and food supplements with probiotics taken in the previous 30 days
4. Ability to follow personal hygiene care
5. The will to cooperate during the study
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
150
Participant exclusion criteria
1. Women with clinical symptoms of yeast or bacterial vaginitis (e.g. burning, itching, odor fish, vaginal discharge, leucorrhea)
2. Ongoing antimicrobial drugs treatment for vaginal infections
3. Laboratory confirmed bacterial infections (exclusion in case of t0 Nugent score > 7)
4. Menopause
5. Pregnancy (drop-out in case of pregnancy during the study)
6. Chronic antibiotic treatment
7. Chronic corticosteroid treatment
8. Immunodeficiency
9. Diabetes
10. Vaginal probiotics used in the previous 30 days
11. Participation to any clinical studies which could influence genitourinary tract flora
Recruitment start date
30/09/2015
Recruitment end date
16/05/2016
Locations
Countries of recruitment
Romania
Trial participating centre
Metropolitan Hospital
Serban Voda Ave, no. 95-101, district 4
Bucharest
040204
Romania
Trial participating centre
Clinica Obstetrica-Ginecologie II "Dominic Stanca"
57th, Boulevard 21 Decembrie 1989
Cluj-Napoca
400124
Romania
Trial participating centre
Clinical Hospital of Obstetrics and Gynecology "Cuza Vodă"
34th Cuza Vodă Street
Iași
700038
Romania
Sponsor information
Organisation
Proge Farm Srl
Sponsor details
Largo Donegani 4/A
Novara
28100
Italy
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Proge Farm Srl
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The dissemination of study results are planned to be published in a high-impact peer reviewed journal at the end of July 2017.
IPD sharing statement
The datasets generated during and/or analysed during the current study (source documentation, CRFs) will be stored in a repository (CEBIS warehouse). Consent was obtained from participants.
Intention to publish date
31/07/2017
Participant level data
Stored in repository
Results - basic reporting
Publication summary