The present study aims to compare the effects of fluconazole(150mg) with vaginal(lactovag) and oral(lactofem) probiotic capsules with fluconazole(150mg) on vulvovaginal candidiasis. This randomized, double blind study is conducted on 70 females suffering from vulvovaginal candidiasis. The study subjects are divided into two groups of 35 through random allocation vulvovaginal candidiasis. The diagnosis criteria are observation of yeast and pseudohyphae in gram stain. For group 1, vaginal and oral probiotic capsules are prescribed for 14 and 28 days respectively plus fluconazole(150mg) for single vulvovaginal candidiasis whereas women with recurrent vulvovaginal candidiasis will be prescribed with 3 fluconazole(150mg) weekly. While, for the second group, oral and vaginal placebo are prescribed for 14 and 28 days respectively plus fluconazole(150mg) for single vulvovaginal candidiasis whereas women with recurrent vulvovaginal candidiasis will be prescribed with 3 fluconazole(150mg) weekly.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090529710N1
Registration date:2016-09-30, 1395/07/09
Registration timing:prospective
Last update:
Update count:1
Registration date
2016-09-30, 1395/07/09
Registrant information
Name
Mehdi Nazeri
Name of organization / entity
Department of Medical Parasitology and Mycology, Medical faculty, kashan university of medical scien
Country
Iran (Islamic Republic of)
Phone
+98 31 5555 1112
Email address
nazeri_me@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
1-Vice chancellor for Research & Technology, Kashan University of Medical Sciences; 2- zist takhmir company
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral and vaginal administration probiotic in treatment of women with vaginal candidiasis
Public title
Effect of oral and vaginal administration probiotic in treatment of women with vaginal candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: married non pregnant women aged 18-45 years old; absence of menstruation at the time of attendance; not using vaginal medications, antibiotics , immonosupressive drugs and exogenous hormones such as oral contraceptives since 2 weeks before starting the research; not having intercourse or using vaginal douche within the last 24 hours; absence of any diagnose medical disease such as diabetis and other auto immune diseases, by asking the patient; verification of vulvovaginal candidiasis resulted clinical symptoms and KOH positive examples and cultivation.
Exclusion criteria: allergic reactions of fluconazole, lactovag and lactofem; pregnancy during therapy; compulsion to use antibiotics or other anti fungal drugs.
Age
From 18 years old to 55 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Scinces and Health Services
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN
City
kashan
Postal code
8715988141
Approval date
2016-07-10, 1395/04/20
Ethics committee reference number
IR.KAUMS.REC.1395.30
Health conditions studied
1
Description of health condition studied
Vulvovaginal Candidiasis
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
Vaginal candidiasis symptoms
Timepoint
1 month (30dayes ) after the use of probiotics or placebo
Method of measurement
questionnaire
Secondary outcomes
1
Description
Dirct smear and Culture
Timepoint
1 month after initial fluconazole treatment with probiotics or placebo
Method of measurement
culture
Intervention groups
1
Description
Oral Fluconazol treatment with Oral probiotic capsules containing Lactobacillus acidophilus,Lactobacillus plantarum,
Lactobacillus fermentum, Lactobacillus gasseri 1×10 9 colony are known as lactofem for once a day for 27 days(4 weeks) plus Vaginal probiotic capsules containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus gasseri, Lactobacillus plantarum 1×10 9colony are known as lacto Vage for once every night for 14days(4 weeks)
Category
Treatment - Drugs
2
Description
Oral Fluconazol treatment with Oral placebo for once a day for 27 days(4 weeks) plus Vaginal placebo for once every night for 14days(4 weeks)