The purpose of this study was to determine the effect of vaginal probiotics (vaginal capsule called lacto flora fem) on improving the role of metronidazole in the treatment of patients with bacterial vaginitis.
Design
Randomized, parallel groups trial with blinding
Settings and conduct
The study is done in Imam Reza Clinic in patients and medical personnel are kept blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Women with bacterial vaginitis based on Amsel criteria
2. Married and between the ages of 18-48
3. Willing to cooperate
Exclusion criteria: 1- Patients with immunodeficiency or HIV positive individuals
2. People with genital and urinary tract infections
3. Antibiotic users within two weeks before entering the study
4. Patients with vaginal candidiasis
5 patients postmonpause
6. Pregnant women or during lactation
7. Patients who do not allow pelvic examination
Intervention groups
Intervention group - treated with metronidazole orally twice daily (morning and night) for 7 days and after treatment every three days with a single suppository containing probiotics for 3 weeks.
Control group - treated with metronidazole orally twice daily (morning and night) for 7 days and placebo every 3 nights for 3 weeks.
Main outcome variables
Clinical symptoms of bacterial vaginitis
PH
The Amsel Criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180612040071N2
Registration date:2020-01-03, 1398/10/13
Registration timing:registered_while_recruiting
Last update:2020-01-03, 1398/10/13
Update count:0
Registration date
2020-01-03, 1398/10/13
Registrant information
Name
Parisa Mamivand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3616 3625
Email address
Parisa.mamivand00@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-26, 1398/09/05
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotic on treatment of bacterial vaginitis and preservation of vaginal bacterial flora in patients treated with metronidazole
Public title
Effect of probiotic on treatment of bacterial vaginitis and preservation of vaginal bacterial flora in patients treated with metronidazole
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with bacterial vaginitis according to the Amsel criteria
married
18-48 years old
Exclusion criteria:
People with immunodeficiency disease and HIV
People with genital and urinary tract infections
Antibiotic users within two weeks prior to inclusion
Patients with candidiasis vaginitis
Menopause
Pregnant women or during lactation
Patients who do not allow pelvic examination
Age
From 18 years old to 48 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with inclusion criteria are randomized by using 4&6 blocks method. Randomization list is prepared before starting the intervention. Patients go under special treatment based on randomize allocation. Patient division conducts by the clerk of the clinic who is blinded to the intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
patients and therapist are blinded to the type of treatment due to similarity of the placebo and Lacto Flora Fem in shape.drug form and route of administration are similar. During assessment gynecologist will be blinded to the treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Scinces and Health Services
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN
City
kashan
Province
Isfehan
Postal code
8715988141
Approval date
2019-08-26, 1398/06/04
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.067
Health conditions studied
1
Description of health condition studied
bacterial vaginosis
ICD-10 code
N70-N77
ICD-10 code description
Inflammatory diseases of female pelvic organs
Primary outcomes
1
Description
Bacterial vaginitis symptoms
Timepoint
1 month (30dayes ) after the use of probiotics or placebo
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients are treated with metronidazole orally twice daily (morning and night) for 7 days and then treated with probiotic suppository every 3 days for 3 weeks.
Category
Treatment - Drugs
2
Description
Control group: Patients are treated with metronidazole orally twice daily (morning and night) for 7 days and then treated with placebo suppository every 3 days for 3 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Dr. Zahra Vahedipoor
Street address
Imam Reza Clinic, Beheshti Ave, Kashan
City
kashan
Province
Isfehan
Postal code
1134845764
Phone
+98 31 5546 6301
Email
zahravahedpoor@g.commail
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Hamidi
Street address
5th of Qotb –Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
+98 31 5554 1112
Email
parisa.mamivand00@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mehdi Nazeri
Position
Assistant Professor of Medical Mycology
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
5th of Qotb –e Ravandi Blvd, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 1112
Fax
+98 31 5554 1112
Email
nazeri_me@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mehdi Nazeri
Position
Assistant Professor of Medical mycology
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
5th of Qotb –e Ravandi Blvd, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 1112
Email
nazeri_me@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mehdi Nazeri
Position
Assistant Professor of Medical Mycology
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
5th of Qotb –e Ravandi Blvd, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 1112
Fax
+98 31 5554 1112
Email
nazeri_me@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
we express only clinical and laboratory outcomes
When the data will become available and for how long
Information will be published as article and final report
To whom data/document is available
Access limitation is not considered
Under which criteria data/document could be used
The final report and article will be available for other researchers
From where data/document is obtainable
Library of Kashan University of Medical Sciences
What processes are involved for a request to access data/document