Objectives: This study aims to determine the effect of complementary therapy of vaginal prebiotic gel with tablet metronidazole on treatment and recurrence of bacterial vaginosis. Design: A double blind randomized controlled trial. Setting and conduct: This study will be conducted in Nasir abad health care center. Eligible women will be randomly assigned into 2 groups of 50 subjects with block sizes of 4 and 6. A person from research team not involved in the recruitment and assigning participants will generate the allocation sequence. Opaque sealed sequentially numbered envelops will be used for allocation concealment. Major inclusion criteria: married; diagnosis of bacterial vaginosis with Amsel criteria and the Nugent scoring system; have willing to participate to study. Exclusion criteria: Having abnormal vaginal bleeding; having other vaginal infections such as candidiasis and trichomoniasis. Interventions: After diagnosis bacterial vaginosis, in addition to metronidazole tablet 250 milligrams 3 times a day (each 8 hours) for 7 days, the patient's will be used prebiotic vaginal gel one applicator (5 milligrams) every night for 7 nights. The control group will use metronidazole tablet 250 milligrams 3 times a day (each 8 hours) for 7 days and placebo vaginal gel one applicator (5 milligrams) every night for 7 nights. Main outcome measures: Clinical and laboratory criteria based on amsel and nugent scoring system; malodon discharge; itching; dyspareunia; having bad smell during sexual and secondary outcomes include: assessment of vaginal pH; client satisfaction; change in Clue cells will be evaluated baseline, 10±1 day after intervention, 12±1 week after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121721917N5
Registration date:2016-02-03, 1394/11/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-03, 1394/11/14
Registrant information
Name
Sevil Hakimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
hakimis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-02-09, 1394/11/20
Expected recruitment end date
2016-06-09, 1395/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of prebiotic vaginal gel supplement with metronidazole ablet on treatment and recurrence of bacterial vaginosis
Public title
Effect of Complementary therapy of vaginal prebiotic gel with metronidazole tablet on treatment and recurrence of bacterial vaginosis: a randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: 18 to 35 years old; married; diagnosis of bacterial vaginosis with contemporary presence of at least 3 out of 4 Amsel criteria and gain score 4 to 6 with clue cells or score 7 to 10 without clue cells in the Nugent scoring system; have willing to participate to study; husband’s monogamous; absence of menstruation during the intervention. Exclusion criteria: pregnant or breastfeeding, or menopause; having abnormal vaginal bleeding; consumption of vaginal medication; douching during 48 hours ago; use of alcohol and smoking; use of anticoagulants such as Coumadin and Disulfiram; having other vaginal infections such as candidiasis and trichomoniasis; having known medical disease such as diabetes, thyroid disease and liver diseases according to patient’s report; not having tendency to use prebiotic gel.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not 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 Tabriz University of Medical Sciences
Street address
Azadi avenue, Golgasht street,third floor, number 2 central building,research and technology department, Tabriz University of Medical Sciences
City
Tabriz
Postal code
118-51665
Approval date
2015-06-28, 1394/04/07
Ethics committee reference number
TBZMed.REC.1394.736
Health conditions studied
1
Description of health condition studied
Bacterial vaginosis
ICD-10 code
N73.9
ICD-10 code description
Female pelvic inflammatory disease, unspecified
2
Description of health condition studied
Bacterial vaginosis
ICD-10 code
N74.8
ICD-10 code description
Female pelvic inflammatory disorders in other diseases classified elsewhere
3
Description of health condition studied
Bacterial vaginosis
ICD-10 code
N76.8
ICD-10 code description
Other specified inflammation of vagina and vulva
Primary outcomes
1
Description
Clinical and laboratory criteria based on Amsel and Nugent scoring system
Timepoint
Baseline, 10±1 day after intervention, 12±1 week after intervention
Method of measurement
Measured by clinical measurements of diseases and laboratory tests
2
Description
Malodon discharge
Timepoint
Baseline, 10±1 day after intervention, 12±1 week after intervention
Method of measurement
Measured by asking from patient
3
Description
Itching
Timepoint
Baseline, 10±1 day after intervention, 12±1 week after intervention
Method of measurement
Measured by asking from patient
4
Description
Dyspareunia
Timepoint
Baseline, 10±1 day after intervention, 12±1 week after intervention
Method of measurement
Measured by asking from patient
5
Description
Having bad smell during sexual intercourse
Timepoint
Baseline, 10±1 day after intervention, 12±1 week after intervention
Method of measurement
Measured by asking from patient
Secondary outcomes
1
Description
Assessment of vaginal pH
Timepoint
Baseline, 10±1 day after intervention, 12±1 week after intervention
Method of measurement
pH paper scale
2
Description
Client satisfaction
Timepoint
Baseline, 10±1 day after intervention, 12±1 week after intervention
Method of measurement
Self-report
3
Description
Change in Clue cells
Timepoint
Baseline, 10±1 day after intervention, 12±1 week after intervention
Method of measurement
direct observation
Intervention groups
1
Description
Intervention group: After diagnosis bacterial vaginosis, in addition to Metronidazole tablet 250 milligrams 3 times a day (each 8 hours) for 7 days, the patient's will be used Prebiotic vaginal gel one applicator (5 milligrams) every night for 7 nights
Category
Treatment - Drugs
2
Description
The control group will use Metronidazole tablet 250 milligrams 3 times a day (each 8 hours) for 7 days and placebo vaginal gel one applicator (5 milligrams) every night for 7 nights
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nasir Abad health care center
Full name of responsible person
Faranak Farhan
Street address
east Hatami, Jannat Abad street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Rashidi Mohammad Reza
Street address
Number 2 central building, third floor, research and technology department, Golgasht street, Azadi avenue, Tabriz University of Medical Sciences
City
Tabriz
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, Tabriz University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Women’s Reproductive Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Mostafa Ghare Baghi Parvin
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Women’s Reproductive Health Research Center, Tabriz University of Medical Sciences
Proportion provided by this source
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
Tabriz University of Medical Sciences
Full name of responsible person
Sevil Hakimi
Position
PhD of reproductive health
Other areas of specialty/work
Street address
South Shariati Street, Nursing & Midwifery Faculty, Tabriz University of Medical Sciences
City
Tabriz
Postal code
3417174914
Phone
+98 41334796770
Fax
Email
Hakimis@tbzmed.ac.ir; hakimisevil@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sevil Hakimi
Position
PhD of reproductive health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
3417174914
Phone
+98 41334796770
Fax
Email
Hakimis@tbzmed.ac.ir; hakimisevil@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Faranak Farhan
Position
MS student of midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
3417174914
Phone
+98 41334796770
Fax
Email
faranak.farhan39@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)