Determining the effect of lactofem capsule on the treatment of bacterial vaginosis
Design
This study will be performed as a triple-blind randomized clinical trial on 72 eligible pregnant women. Pregnant mothers will be divided into two groups based on stratified random sampling method and table of random numbers, in which for numbers zero to 4 in random numbers table, AB sequence and for numbers 5 to 9, BA sequence will be selected.
Settings and conduct
The present study will be performed in the gynecology clinic of Asali Hospital in Khorramabad. People in the intervention group will be given one lactofem capsule daily for one month, and in the control group, placebo will be used according to the same instructions. The study will be triple-blind and patients, researcher and statistical analyst will be unaware of patients' intervention group.
Participants/Inclusion and exclusion criteria
Inclusion requirements: Gestational age over 12 weeks, Bacterial vaginosis infection .
Exclusion requirements: Concomitant infection with Trichomonas or candidiasis; Gestational diabetes, Simultaneous urinary tract infection, Rupture of amniotic membrane, Immune system defects, Inflammatory bowel disease.
Intervention groups
Intervention group (lactofem capsule): pregnant women will receive one lactofem capsule orally daily for one month. Control group (placebo): patients willreceive placebo, a capsule completely similar to the main drug form. In order to prevent the ethical consideration about control group deprivation, intervention and control groups both will receive routine treatment.
Main outcome variables
Infection status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090701002114N7
Registration date:2020-11-16, 1399/08/26
Registration timing:registered_while_recruiting
Last update:2020-11-16, 1399/08/26
Update count:0
Registration date
2020-11-16, 1399/08/26
Registrant information
Name
Fatemeh Yari
Name of organization / entity
Lorestan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1222 6450
Email address
yari.f@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-14, 1399/08/24
Expected recruitment end date
2021-01-13, 1399/10/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lactofem capsule on the treatment of bacterial vaginosis in pregnant women
Public title
The effect of lactofem on the vaginosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age over 12 weeks
Bacterial vaginosis infection
Exclusion criteria:
Concomitant infection with Trichomonas or candidiasis
Gestational diabetes
urinary tract infection
Rupture of the amniotic sac
Immune system defects
Inflammatory bowel disease
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be randomly assigned to the study after visiting the gynecology clinic. Randomization will be in the form of blocking in such a way that the method of replacement blocks is used within each floor. The blocks will be binary, consisting of AB and BA. The randomization tool will be a table of random numbers, that using the sequence AB for numbers zero through 4 in the random number table and the sequence BA for 5 to 9.It should be noted that the letter A means the intervention group and the letter B means the control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study will be a three-way blind and the patient, researcher and statistical analyst of the patients' group therapy have no information and the decoder is outside the research team. The drug under study (lactofem) and placebo in a completely similar shape and appearance, each of which is 30 in the same bottle instead of the drug will be provided to the subjects based on random allocation. It should be noted that the drug content of each The bottles are code-tagged on the bottles by the pharmacist consultant and the research team is not aware of their interpretation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Lorestan University of Medical Sciences
Street address
Office of Research Ethics Committee, Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences, University Campus Complex, km 3 of Khorramabad Boroujerd Road, Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2019-03-05, 1397/12/14
Ethics committee reference number
IR.LUMS.REC.1397.132
Health conditions studied
1
Description of health condition studied
Bacterial vaginosis infection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bacterial vaginosis
Timepoint
Evaluation of vaginal infection at the beginning of the study and one month after taking Lactofem capsules
Method of measurement
Vaginal examination by physician
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: pregnant women who have a bacterial vaginosis infection according to a doctor's examination will be treated with Lactofem oral capsules and will take one capsule daily for one month. After a month, they will be examined by a doctor.
Category
Treatment - Drugs
2
Description
Control group: In this group, instead of lactofem capsule, a placebo capsule with a similar shape and appearance will be used. Placebo will be used daily for a month. After a month, they will be examined by a doctor.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Asalian Hospital
Full name of responsible person
Dr. Masoumeh Ghaffarzadeh
Street address
Asalian Hospital,14th Street, Palestine Alley
City
Khorramabad
Province
Lorestan
Postal code
6818795895
Phone
+98 66 3340 6099
Email
asali.hospital@lums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Ibrahim Fallahi
Street address
Medical school, 4 km Khorramabad Boroujerd Road, Kamalvand
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3312 0172
Email
falahi.e@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Fatemeh Yari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Medical school.,4 km Khorramabad Boroujerd Road.,Kamalvand
City
Khorramabad
Province
Lorestan
Postal code
381351698
Phone
+98 66 3312 0133
Email
yari.f@lums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Fatemeh Yari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Medical school.,4 km Khorramabad Boroujerd Road.,Kamalvand
City
Khorramabad
Province
Lorestan
Postal code
381351698
Phone
+98 66 3312 0133
Email
yari.f@lums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Fatemeh Yari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Medical school.,4 km Khorramabad Boroujerd Road.,Kamalvand
City
Khoramabad
Province
Lorestan
Postal code
381351698
Phone
+98 66 3312 0133
Email
yari.f@lums.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
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
It is possible to share all the data while maintaining the principle of not mentioning the names of individuals
When the data will become available and for how long
One year after the publication of the related article
To whom data/document is available
Researchers of university centers
Under which criteria data/document could be used
For additional research and production of probiotic therapeutic compounds, the data of the present study can be used after obtaining permission and approval from the Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences
From where data/document is obtainable
Refer to the project manager, Dr. Fatemeh Yari, with email address yari1672@yahoo.com, and contact number 09163613621
What processes are involved for a request to access data/document
After completing the research and publishing the relevant article, individuals can apply to the Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences to receive documents and after obtaining permission from this department, send a confirmation from the Vice Chancellor for Research to the project manager. Can access documentation.