Comparing the effect of probiotic and fluconazole in treatment and recurrent of vaginal candidiasis
Design
This is a three-blind randomized controlled trial with two intervention groups that will be performed on 80 women of reproductive age with candida vaginitis. Eligible individuals are placed in groups randomly using a computer random table through random blocking of four and six and clients in a ratio of 1: 1 allocation to two groups (recipient of fluconazole tablets and probiotic placebo and recipient of probiotic capsules and Fluconazole placebo)
Settings and conduct
People with candida vaginitis referred to Taleghani and Zahrai gynecological clinics in Tabriz are randomly assigned to two groups of drug recipients.In order to Allocation Concealement, the drugs will be placed in numbered consecutive frosted jars and delivered to participants in the order in which they enter the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Married women aged 15-49 -Positive culture of secretions from the candidate's point of view-Be literate-Willingness to participate in the study and the possibility of visiting the clinic at the requested times-Having a contact phone -Being a resident of Tabriz
Exclusion criteria: Pregnancy, lactation and menopause - Use of antibiotics and immunosuppressive drugs and use of vaginal drugs during the last two weeks -Currently taking oral contraceptives-Having autoimmune diseases - Having chronic diseases such as diabetes, anemia, hypothyroidism, etc. - Having menstrual bleeding during the visit of the participant -Abnormal uterine bleeding-Non-candida vaginitis -Recurrent vulvovaginitis -Symptoms of drug allergy-Consumption of any probiotic product
Intervention groups
Receiver of fluconazole tablets and probiotic placebo
Receiver of probiotic capsules and fluconazole placebo
Main outcome variables
Negative culture on day 35-40 and 60-65
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110826007418N5
Registration date:2021-03-03, 1399/12/13
Registration timing:prospective
Last update:2021-03-03, 1399/12/13
Update count:0
Registration date
2021-03-03, 1399/12/13
Registrant information
Name
Parisa Yavarikia
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
yavarikiap@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-10, 1399/12/20
Expected recruitment end date
2021-06-10, 1400/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of probiotic and fluconazole in treatment and recurrent of vaginal candidiasis: A three-blind randomised controlled trial
Public title
omparing the effect of probiotic and fluconazole in treatment and recurrent of vaginal candidiasis: A three-blind randomised controlled trial
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Married women aged 15-49 (lack of virginity)
Positive culture of discharge from the candidate's point of view
Be literate
Willingness to participate in the study and the possibility of visiting the clinic at the requested times
Having a contact phone
Living in the city of Tabriz
Exclusion criteria:
Pregnancy, lactation and menopause
Use of antibiotics and immunosuppressive drugs (corticosteroids, etc.) and use of vaginal drugs during the last two weeks
Currently taking oral contraceptives according to the participant
Having autoimmune diseases
Having chronic diseases such as diabetes, anemia, hypothyroidism, etc.
Having menstrual bleeding during the visit of the participant
Abnormal uterine bleeding
Non-candidal vaginitis
Recurrent vulvovaginitis (four or more cases during the year)
Symptoms of drug allergy
Consumption of any probiotic product (supplements, food, etc.)
Age
From 15 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Placement of individuals in groups is done randomly using a computer random table through random blocking of four and six and clients in a ratio of 1: 1 allocation to two groups (recipient of fluconazole tablets and probiotic placebo and recipient of probiotic capsules and Fluconazole placebo)
Similar glasses are prepared in terms of appearance, the contents of which are also not visible, and each glass contains contains 30 capsules and one tablet and includes two types: the first type contains one pink fluconazole tablet 150mg and 30 capsules 500mg of probiotic placebo, and the second contains The second type contains 30 500mg probiotic capsules and one 150mg fluconazole placebo tablet. Fluconazole placebo is pink. Random allocation will be provided by the person not involved in the sampling. In order to Allocation Concealement, the drugs will be placed in numbered consecutive frosted jars and delivered to participants in the order in which they enter the study.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Similar glasses are prepared in terms of appearance, the contents of which are also not visible, and each glass contains contains 30 capsules and one tablet and includes two types: the first type contains one pink fluconazole tablet 150mg and 30 capsules 500mg of probiotic placebo, and the second contains The second type contains 30 500mg probiotic capsules and one 150mg fluconazole placebo tablet. Fluconazole placebo is pink. Random allocation will be provided by the person not involved in the sampling. In order to Allocation Concealement, the drugs will be placed in numbered consecutive frosted jars and delivered to participants in the order in which they enter the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Nursing & Midwifery Faculty, South Shariati Streetwifery, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2020-12-07, 1399/09/17
Ethics committee reference number
IR.TBZMED.REC.1399.848
Health conditions studied
1
Description of health condition studied
vaginal candidiasis
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
Frequency of negative culture in two intervention groups
Timepoint
Day 40-35 after starting treatment and day 65-60 after starting treatment
Method of measurement
Cultivation in the laboratory
Secondary outcomes
1
Description
Patients complain of foul-smelling discharge
Timepoint
Day 35-40 and day 60-65 after starting treatment
Method of measurement
Questionnaire of signs and symptoms of the person
2
Description
Patients complain of itching
Timepoint
Day 35-40 and day 60-65 after starting treatment
Method of measurement
Questionnaire of signs and symptoms of the person
3
Description
Patients complain of burning
Timepoint
Day 35-40 and day 60-65 after starting treatment
Method of measurement
Questionnaire of signs and symptoms of the person
4
Description
Patients complain of inflammation and vaginal erythema
Timepoint
Day 35-40 and day 60-65 after starting treatment
Method of measurement
Questionnaire of signs and symptoms of the person
5
Description
Patients complain of frequent urination
Timepoint
Day 35-40 and day 60-65 after starting treatment
Method of measurement
Questionnaire of signs and symptoms of the person
6
Description
Patients complain of urinary incontinence
Timepoint
Day 35-40 and day 60-65 after starting treatment
Method of measurement
Questionnaire of signs and symptoms of the person
7
Description
Patients complain of pain during intercourse
Timepoint
Day 35-40 and day 60-65 after starting treatment
Method of measurement
Questionnaire of signs and symptoms of the person
8
Description
Vaginal pH
Timepoint
Day 35-40 and day 60-65 after starting treatment
Method of measurement
Checklist for recording observations and clinical results
9
Description
Satisfaction rate
Timepoint
Day 35-40 after starting treatment
Method of measurement
Personal Satisfaction Questionnaire
10
Description
Adverse events during the intervention
Timepoint
Any time of study
Method of measurement
Checklist for side effects
Intervention groups
1
Description
First intervention group :Take one dose of 150 mg fluconazole tablets and then a daily 500 mg probiotic placebo capsule (containing starch and made by the researcher) for one month. Day 12-15 Phone follow-up will be done and in addition to emphasizing the regular use of prescribed drugs and other instructions, the candidiasis symptoms questionnaire will be completed by phone. The first and second follow-up (in person) is 35-40 days and 60-65 days after the start of treatment. From the pH meter paper, the vaginal pH is determined and recorded in a checklist, and a sample will be taken from the vaginal canal for laboratory culture.
Category
Treatment - Drugs
2
Description
The second intervention group: Take one dose of 150 mg placebo fluconazole tablets (which contain starch and will be made by the researcher) and then take a daily probiotic capsule containing containing Lactobacillus acidophilus daily at a dose of 〖10〗^9 CFU/g CFU / g for one month (Probiotic powder is prepared in the order of the researcher from Hansen company in 25 gram packages and is poured into the capsule by the relevant personnel in Tabriz School of Pharmacy and Medical Sciences.). Day 12-15 Phone follow-up will be done and in addition to emphasizing the regular use of prescribed drugs and other instructions, the candidiasis symptoms questionnaire will be completed by phone. The first and second follow-up (in person) is 35-40 days and 60-65 days after the start of treatment. From the pH meter paper, the vaginal pH is determined and recorded in a checklist, and a sample will be taken from the vaginal canal for laboratory culture.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Zahra Mollazadeh Narestan
Street address
Taleghani hospital, Railway Square, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 0364
Email
zahra.m8565@gmail.com
2
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Zahra Mollazadeh Narestan
Street address
Alzahra hospital, South Army Street, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 0364
Email
zahra.m8565@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Research department, third floor, central construction number 2, Tabriz Medical Science University, Golgasht Street, Azadi Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3334 1315
Fax
Email
rashidi@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Mollazadeh Narestan
Position
MSc student in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing & Midwifery Faculty, South Shariati Street Tabriz
City
Tabriz
Province
West Azarbaijan
Postal code
5138947-977
Phone
+98 41 3479 0364
Fax
Email
zahra.m8565@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parisa Yavarikia
Position
Nursing & Midwifery, Tabriz
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nursing & Midwifery Faculty, South Shariati, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947-977
Phone
+98 41 3479 6770
Fax
Email
yavarikiap@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parisa Yavarikia
Position
Nursing & Midwifery, Tabriz
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nursing & Midwifery Faculty, South Shariati, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947-977
Phone
+98 41 3479 6770
Email
yavarikiap@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data sets are to be shared after deidentified IPD.
When the data will become available and for how long
Data will become available 6 months after publication.
To whom data/document is available
data is available for people working in academic institutions.
Under which criteria data/document could be used
Obligation to observe ethics.
From where data/document is obtainable
E-mail: yavarikiap@tbzmed.ac.ir
What processes are involved for a request to access data/document
A request to access data/document will be respond during one week.