Protocol summary
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Study aim
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The compare the effects of fluconazole(150mg) with vaginal(lactovag) and oral(lactofem) probiotic capsules with Fluconazole(150mg) on vulvovaginal candidiasis.
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Design
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A randomized, double blinded controlled clinical trial with a parallel group design of 80 patients, enrolled between July 2017and April 2019, and followed for 30-35 days.
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Settings and conduct
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Imam Reza Gynecology Clinic and Naghavi Hospital of Kashan
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 1- married women aged 18-45 years old
2- None pregnant absence of menstruation
3- Not using vaginal medications, antibiotics, immonosupressive drugs and exogenous hormones such as oral contraceptives since 2 weeks before starting the research
4- Not having intercourse or using vaginal douche within the last 24hours
5- Absence of any diagnose medical disease such as diabetis and other auto immune diseases
6- Vulvovaginal candidiasis based on clinical symptoms and laboratory finding
Exclusion criteria: 1- Allergic reactions to fluconazole, lactovag and lactofem
2- Pregnancy during therapy
3- Compulsion to use antibiotics or other anti fungal drugs.
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Intervention groups
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Patients with vulvovaginal Candidiasis are randomly assigned to two groups. Group 1 will be treated with vaginal and oral probiotics for 14 and 28 days, respectively, with one oral fluconazole (150 mg), and in cases of recurrent vaginitis, receive three fluconazoles once every 72 hours. Group 2 will be treated with vaginal and oral placebo for 14 and 28 days, respectively, with one oral fluconazole (150 mg), and in recurrent vaginitis, three fluconazole will be treated every 72 hours.Patients are evaluated after 35-30 days based on clinical symptoms and laboratory findings.
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Main outcome variables
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Clinical symptoms: itching, burning, discharge, and dyspareunia
Laboratory findings: Direct smear and positive culture
General information
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Reason for update
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Increase the number and time of sampling.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016090529710N1
Registration date:
2016-09-30, 1395/07/09
Registration timing:
registered_while_recruiting
Last update:
2019-11-09, 1398/08/18
Update count:
1
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Registration date
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2016-09-30, 1395/07/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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1-Vice chancellor for Research & Technology, Kashan University of Medical Sciences; 2- zist takhmir company
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Expected recruitment start date
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2016-07-20, 1395/04/30
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Expected recruitment end date
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2018-03-27, 1397/01/07
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of oral and vaginal administration probiotic in treatment of women with vaginal candidiasis
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Public title
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Effect of oral and vaginal administration probiotic in treatment of women with vaginal candidiasis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
married women aged 18-45 years old
none pregnant
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 24hours
absence of any diagnose medical disease such as diabetis and other auto immune diseases, by asking the patient
not having intercourse or using vaginal douche within the last 24 hours
verification of vulvovaginal candidiasis resulted clinical symptoms and KOH positive smear and culture
Exclusion criteria:
allergic reactions to fluconazole, lactovag and lactofem
pregnancy during therapy
compulsion to use antibiotics or other anti fungal drugs.
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Age
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From 18 years old to 55 years old
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Gender
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Female
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be done by simple method and using random numbers generated by computer software (Stat Trek software). In this method the computer selects random numbers. with consideration of numbers, the two groups are randomized.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Placebo will be used to achieve participants,Care provider and investigators will be masking. The researchers and patients will be concealed until the final analyses by a trained staff.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-07-10, 1395/04/20
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Ethics committee reference number
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IR.KAUMS.REC.1395.30
Health conditions studied
1
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Description of health condition studied
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Vulvovaginal Candidiasis
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ICD-10 code
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B37.3
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ICD-10 code description
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Candidiasis of vulva and vagina
Primary outcomes
1
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Description
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Vaginal candidiasis symptoms
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Timepoint
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35-30 days after starting probiotic or placebo treatment
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Method of measurement
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questionnaire
Secondary outcomes
1
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Description
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Dirct smear and Culture
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Timepoint
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30-30 days after starting treatment with fluconazole and probiotic or placebo
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Method of measurement
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culture and direct smear
Intervention groups
1
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Description
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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)
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Category
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Treatment - Drugs
2
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Description
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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)
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Category
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Placebo
1
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Sponsor
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Grant name
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Vice Chancellor of Research & Technology of Kashan University of Medical Scinces
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Scinces and Health Services
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available