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The effect of the Lactofem oral probiotic Capsule on the Lactobacilli colonization and some parameters of the vaginal health in women 18-55 year’s old admitted to the Health Centers of Shiraz University Medical Science in 2015.

Protocol summary

Summary
The purpose of the study and designing of the study performance: The effect of oral Lactofem probiotic capsule on lactobacillus colonization and some vaginal health indices during the age of 18 up to 55 years. This study has been double-blind and placebo. Inclusion criteria: The age 18-55 years; married; nonpregnant women; willing to participate in study; having natural menstrual cycles; nonsmokers; Nugent score = 4-6; pH >4.5; clinically, the samples not suffered any vaginitis; not suffered from such disease as liver, heart, kidney, diabetes, nervous system ailments, immunodeficiency, sexually transmitted illnesses; non abnormal vaginal bleedings. Exclusion criteria: pregnancy occurrence during the study; the use of vast spectrum antibiotics, hormonal drugs, alcohol, anticoagulation drugs and the recent month immunosuppressive; infection existence; ulcers, injury and abnormal secretions in the vulve, vagina and cervix examinations; sensitivity symptoms against oral probiotic; suspension with going on the study participation. Target sample size: selection of eighty individuals of the qualified study community. Random allocation of subjects into two groups. Intervention: oral probiotic is given to a group and placebo to another one. Tracking people: vaginal pH measurement, lactobacillus culture and assigning of Nugent score respectively after 10, 30, 60 and 70 days of consuming probiotic or placebo in two study groups. Outcome study: the effect of oral probiotic on the measured pH, lactobacillus culture and Nugent score.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015062322892N1
Registration date: 2015-09-04, 1394/06/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-04, 1394/06/13
Registrant information
Name
Seyedeh Zohreh Balaghi
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 2404
Email address
stud2297639521@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
7th Floor, Vice chancellor for Research, Shiraz University of Medical Sciences, Central department of Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran. Postal Code: 7174917787, Tel: 00987132122389
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the Lactofem oral probiotic Capsule on the Lactobacilli colonization and some parameters of the vaginal health in women 18-55 year’s old admitted to the Health Centers of Shiraz University Medical Science in 2015.
Public title
The effect of the oral probiotic on some parameters of the vaginal health
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The age 18-55 years; married; nonpregnant women; willing to participate in study; having natural menstrual cycles; nonsmokers; Nugent score = 4-6; pH >4.5; clinically, the samples not suffered any vaginitis; not suffered from such disease as liver, heart, kidney, diabetes, nervous system ailments, immunodeficiency, sexually transmitted illnesses; non-abnormal vaginal bleedings Exit criteria: pregnancy occurrence during the study; the use of vast spectrum antibiotics, hormonal drugs, alcohol, anticoagulation drugs and the recent month immunosuppressive; infection existence; ulcers, injury and abnormal secretions in the vulve, vagina and cervix examinations; sensitivity symptoms against oral probiotic; suspension with going on the study participation
Age
From 18 years old to 54 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Science
Street address
Shiraz University of Medical Science, Zand street, Shiraz
City
Shiraz
Postal code
7134814336
Approval date
2015-06-21, 1394/03/31
Ethics committee reference number
IR.SUMS.REC.1394.47

Health conditions studied

1

Description of health condition studied
Vaginal health
ICD-10 code
T19.2
ICD-10 code description
Foreign body in vulva and vagina

Primary outcomes

1

Description
Vaginal pH
Timepoint
respectively after 10, 30, 60 and 70 days of consuming probiotic or placebo in two study groups
Method of measurement
Test strip Merck Germany

2

Description
Nugent score
Timepoint
respectively after 10, 30, 60 and 70 days of consuming probiotic or placebo in two study groups
Method of measurement
Take smear from vagina with a cotton swab and make a direct smear on a microscope slide . In the laboratory the smears were stained and observed under the microscope to estimate nugent score.

3

Description
lactobacillus colonization of vagina
Timepoint
respectively after 10, 30, 60 and 70 days of consuming probiotic or placebo in two study groups
Method of measurement
Coun Lactobacillus

Secondary outcomes

empty

Intervention groups

1

Description
The oral probiotic capsule which contains a large amount of probiotic such as L. Acidophilus, L. plantarum, L. fermentum and L. gasseri are given one 500 milligram capsule during sixty days.
Category
Treatment - Drugs

2

Description
Placebo capsule which are orally given one capsule per day during 60 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Nader Kazemi Clinic
Full name of responsible person
Mrs Vafaee
Street address
Valiasr Square
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
7th Flat, Central Department of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery
Full name of responsible person
Sara Azima
Position
Faculty Member, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi Square
City
Shiraz
Postal code
7174917787
Phone
+98 71 3647 4258
Fax
Email
azimas@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fatemeh College of Nursing And Midwifery
Full name of responsible person
Sara Azima
Position
Faculty Member, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi Square
City
Fars
Postal code
7174917787
Phone
+98 71 3647 4258
Fax
Email
azimas@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Seyedeh Zohreh Balaghi
Position
Student, MSc in Midwifery
Other areas of specialty/work
Street address
Central Building of Shiraz University of Medical Science, Zand Street,
City
Shiraz
Postal code
7134814336
Phone
+98 71 3730 6873
Fax
Email
stud2297639521@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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