1. Home
  2. Approved trials
  3. » فارسی

Evaluation of the effect of vaginal probiotic products in eliminating Human Papillomavirus in women with HPV

Protocol summary

Study aim
Investigating the effect of vaginal probiotic products in eliminating HPV virus in women
Design
This is a non-blinded randomized clinical trial with a parallel design and a control group. This randomized, phase 2-3 study will be conducted on at least 54 women with human papillomavirus. A simple random method is used for randomization and the participants are assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted at Imam Reza Hospital in Kermanshah, is non- blinded. First, a PCR test is performed for the participants in the laboratory by the resident, and high-risk patients with a positive HPV test result are included in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Age 21-65 years; Married; Being in the follicular period of the menstrual cycle; Not having intercourse and not washing the vagina in the last 48 hours Exclusion criteria: Pregnant, lactating, and smoking women; People who are considered sick based on clinical diagnosis but whose test results are negative; Using vaginal drugs such as creams, suppositories, and vaginal disinfectants in the last 48 hours; Suffering from certain diseases such as liver, heart, kidney disease, diabetes, central nervous system diseases, blood dyscrasias, immune system defects and known sexually transmitted diseases; Use of broad-spectrum antibiotics, antiprostaglandins, hormonal and immunosuppressive drugs, alcohol, and anticoagulant drugs during the last month.
Intervention groups
The intervention group will receive vaginal probiotic capsules (with the trade name Lacto vag, manufactured by the American Food and Drug Company, a pack of 30), two vaginal capsules per week for 6 months. The control group will receive routine treatment.
Main outcome variables
wet smear

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130812014333N200
Registration date: 2023-05-20, 1402/02/30
Registration timing: prospective

Last update: 2023-05-20, 1402/02/30
Update count: 0
Registration date
2023-05-20, 1402/02/30
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vaginal probiotic products in eliminating Human Papillomavirus in women with HPV
Public title
The effect of vaginal probiotic products in eliminating Human Papillomavirus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent Age 21-65 years married being in the follicular period of the menstrual cycle; Not having intercourse and not washing the vagina in the last 48 hours
Exclusion criteria:
Pregnant, lactating and smoking women People who are considered sick based on clinical diagnosis but whose test results are negative Using vaginal drugs such as creams, suppositories and vaginal disinfectants in the last 48 hours Suffering from certain diseases such as liver, heart, kidney disease, diabetes, central nervous system diseases, blood dyscrasias, immune system defects and known sexually transmitted diseases. Use of broad-spectrum antibiotics, antiprostaglandins, hormonal and immunosuppressive drugs, alcohol, and anticoagulant drugs during the last month
Age
From 21 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in a simple random method, after identifying eligible patients, they will be randomly assigned a three-digit dedicated code. The last digit on the right determines the patient group. If this number is 0, 1, 2, 3, 4, it will be assigned to the first intervention group, and if this number is 5, 6, 7, 8, 9, it will be assigned to the second intervention group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2023-01-08, 1401/10/18
Ethics committee reference number
IR.KUMS.MED.REC.1402.020

Health conditions studied

1

Description of health condition studied
human papillomavirus (HPV)
ICD-10 code
B97.7
ICD-10 code description
Papillomavirus as the cause of diseases classified elsewhere

Primary outcomes

1

Description
wet smear
Timepoint
6 months after the start of the study
Method of measurement
Pap smear test

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group will receive vaginal probiotic capsules (with the trade name Lacto vag, manufactured by the American Food and Drug Company, a pack of 30), two vaginal capsules per week for 6 months
Category
Treatment - Drugs

2

Description
The control group will receive routine treatment
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. saba Najafi
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
saba.najafi.k@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Cyrus Jalili
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Saba Najafi
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
saba.najafi.k@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Maryam Zangeneh
Position
Member of the faculty of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza Hospital, School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3426 6780
Email
mzangeneh@kums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Saba Najafi
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
6715847141
Email
saba.najafi.k@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...