The objectives of this randomized controlled trial are to evaluate effect of probiotics yoghurt as a complementary method on improving treatment effect of Metronidazol and preventing recurrence of bacterial vaginosis. It will be conducted on 140 married women aged 15-49 years referring to Alzahra hospital clinics in Tabriz who have bacterial vaginosis (diagnosed by ≥3 Amsel criteria and Nugent score ≥ 4-6 or over 7 with no considering Clue Cells) and are not infected to other vaginal infections. Eligible women will be allocated into two groups using the Block Randomization with block sizes four and six. The intervention group will take Metronidazole oral tablets and probiotic yogurt, while the control group will take Metronidazole oral tablets and yoghurt with no probiotics. Similar packaging will be used to conceal the allocation sequence. The yoghurt packs will be sequentially numbered based on allocation sequence by a person not involved in data collection and analyzing. The patients will be asked to use 100 gr yoghurt packs three times a day for 60 days and come back to the clinic 10± 2 and 90 and 180 ± 7 days after starting treatment for outcome assessment. Outcomes are microbiological cure as assessed by ≤1 Amsel criteria and Nugent score ≤4-6 and clinical cure as reported by patient and clinician at days 10±2 and 90 and 180. Data will be analyzed by Chi-square using SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206243706N13
Registration date:2012-07-14, 1391/04/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-07-14, 1391/04/24
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of Medical Sciences & Infectious disease research center
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of probiotics yoghurt as a complementary method on treatment and recurrence of bacterial vaginosis: a randomized controlled trial
Public title
Effectiveness of probiotics yoghurt on treatment and recurrence of bacterial vaginosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Married, non pregnant, non lactatating women aged 49-15 years
2-diagnosis of bacterial vaginosis by Amsel and Nugent Criteria).
3 - no abnormal vaginal bleeding.
4 - no probable intervening situations with the test results (menstruation at time of smear, having sex during last 48 houres, use of douch during last 48 houres)
5 -giving informeed consent to participate the study and be able to present at the clinic during next 24 houres, once every 2 weeks for next 2 month (to get the yoghurts), and also after 3 months, and after 6 months for assessments.
Exclusion criteria:
1 - use of antibiotics in last 2 weeks.
2 - use of vaginal drugs in last 30 days.
3 - suffering from HIV.
4 - suffering from heart disease and kidney failure.
5 - Having surgery on the colon.
6 – smoking.
7 - Starting to use IUD in the last month or deciding to Insert IUD in following 3 months.
8 - useing immunosuppressive drugs.
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences, Reaserch deputy
Street address
Golgasht
City
Tabriz
Postal code
Approval date
2012-07-02, 1391/04/12
Ethics committee reference number
9156
Health conditions studied
1
Description of health condition studied
Bacterial Vaginosis
ICD-10 code
N76
ICD-10 code description
other inflammation of vagina and vulva
Primary outcomes
1
Description
Microbiological cure
Timepoint
10+-2 days after starting treatment
Method of measurement
Microbiologocal cure as assessed by Amsel criteria and Nugent score
2
Description
Recurrence of bacterial vaginosis
Timepoint
90 and 180 +- 7 days after starting treatment
Method of measurement
Amsel criteria and Nugent score
Secondary outcomes
1
Description
Clinical cure
Timepoint
10 +- 3 days and 90 and 180 +-7 days after starting treatment
Method of measurement
Patient and clinician reports
Intervention groups
1
Description
Intervention group( metronidazol tablet + probiotic yogurt) at first 7 days metronidazol(500 mg Twice a day) then probiotic yogurtdaily for 2 month.
Category
Treatment - Drugs
2
Description
Control group( metronidazol tablet + Pasteurized yogurt)at first 7 days metronidazol(500 mg Twice a day) then Pasteurized yogurt daily for 2 month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital clinics in Tabriz
Full name of responsible person
somayeh ziyadi
Street address
Artesh street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Infectious disease research center
Full name of responsible person
DR.Behrooz Nagili
Street address
Azadi Avenue,Sina educational and treatment center
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Infectious disease research center
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
Nursing & Midwifery faculty
Full name of responsible person
Somayeh Ziyadi
Position
MSc student
Other areas of specialty/work
Street address
Nursing & Midwifery faculty
City
Tabriz
Postal code
Phone
00
Fax
Email
s.ziyadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences, Nursing & Midwifery faculty
Full name of responsible person
Dr.Sakineh Mohamad alizade Charandabi
Position
PhD in reproductive Health,Assistant professor
Other areas of specialty/work
Street address
Nursing & Midwifery faculty
City
Tabriz
Postal code
Phone
00
Fax
Email
alizades@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Nursing & Midwifery facilty
Full name of responsible person
Somayeh Ziyadi
Position
MSc student
Other areas of specialty/work
Street address
Tabriz Nursing & Midwifery facilty
City
Tabriz
Postal code
Phone
Fax
Email
s.ziyadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)