Condition category
Infections and Infestations
Date applied
03/07/2017
Date assigned
17/07/2017
Last edited
14/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Public

Primary contact

Mr Nicu Trincu

ORCID ID

Contact details

222nd Plevnei Road
3rd Floor
Bucharest
060016
Romania

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

www.progefarm.it

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

Publication citations

Additional files

Editorial Notes