Activity and tolerability of L. plantarum P 17630, orally administered 5 x 10 9 CFU/capsule

ISRCTN	ISRCTN12669692
DOI	https://doi.org/10.1186/ISRCTN12669692
EudraCT/CTIS number	2017-002827-97
Secondary identifying numbers	PLANT_2015_RO

Submission date: 03/07/2017
Registration date: 17/07/2017
Last edited: 31/01/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Mr Nicu Trincu
Public

222nd Plevnei Road, 3rd Floor
Bucharest
060016
Romania

Study information

Study design	Multicentre double-blind placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study acronym	PLANTAGYN
Study objectives	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(s)	The Ethics Committee of the University of Medicine & Pharmacy “Târgu Mureş”, Romania, 20/05/2015, ref: No.66
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	20/05/2015
Completion date	16/05/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	150
Key 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
Key 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
Date of first enrolment	30/09/2015
Date of final enrolment	16/05/2016

Locations

Countries of recruitment

Romania

Study participating centres

Metropolitan Hospital

Serban Voda Ave, no. 95-101, district 4
Bucharest
040204
Romania

Clinica Obstetrica-Ginecologie II "Dominic Stanca"

57th, Boulevard 21 Decembrie 1989
Cluj-Napoca
400124
Romania

Clinical Hospital of Obstetrics and Gynecology "Cuza Vodă"

34th Cuza Vodă Street
Iași
700038
Romania

Sponsor information

Proge Farm Srl
Industry

Largo Donegani 4/A
Novara
28100
Italy

Website	www.progefarm.it
"ROR"	https://ror.org/023k9vr64

Funders

Funder type

Industry

Proge Farm Srl

No information available

Results and Publications

Intention to publish date	31/07/2017
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
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 plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2018		Yes	No

Editorial Notes

31/01/2018: Publication reference added.