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Comparing the Efficacy of Probiotic and Antibiotic Combination Therapy with Antibiotic Therapy Alone on the Recurrence of Bacterial Vaginosis

Protocol summary

Study aim
This study aimed to compare the efficacy of probiotic and antibiotic combination therapy with antibiotic therapy alone to prevent the recurrence of bacterial vaginosis.
Design
Parallel-arm, Randomized controlled trial
Settings and conduct
Gynecological Department of Nishtar Hospital, Multan,
Participants/Inclusion and exclusion criteria
Women 18-45 years old having bacterial vaginosis diagnosed according to Amsel's criteria (at least three of the following BV symptoms: Greyish white, thin, homogenous vaginal discharge, vaginal pH >4.5, positive amine test findings, and presence of clue cells (>20%) in a wet smear observed under microscopy, all cured with metronidazole, were enrolled. Patients with a history of allergy against the study drug, pregnant, lactating, menopausal women, history of bleeding from the genital tract of unknown aetiology, women with malignancy of the reproductive tract or any co-morbid condition like AIDS, diabetes, psychiatric illness, or currently using any contraceptive method, and patients using another oral or vaginal probiotic at the time of assessment or receiving antibiotic therapy for another reason were excluded.
Intervention groups
In Group A, probiotics (Lactobacillus plantarum PBS067, Lactobacillus rhamnosus LRH020, and Bifidobacterium animalis lactis BL050) were administered once a day for 14 days following antibiotic treatment (Tab Metronidazole 400mg TDS for seven days). A post-antibiotic therapy placebo (dextrose-filled pill) was administered to Group B (n = 52).
Main outcome variables
Recurrence of bacterial vaginosis

General information

Reason for update
Acronym
PECABAT-RBV
IRCT registration information
IRCT registration number: IRCT20230814059147N1
Registration date: 2024-01-10, 1402/10/20
Registration timing: retrospective

Last update: 2024-01-10, 1402/10/20
Update count: 0
Registration date
2024-01-10, 1402/10/20
Registrant information
Name
Faisal Ramzan
Name of organization / entity
Choudhary Pervaiz Elahi Institute of Cardiology, Multan
Country
Pakistan
Phone
+92 332 6439622
Email address
dr.faisalahmadani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-01, 1401/01/12
Expected recruitment end date
2023-05-01, 1402/02/11
Actual recruitment start date
2022-04-01, 1401/01/12
Actual recruitment end date
2023-04-01, 1402/01/12
Trial completion date
2023-07-01, 1402/04/10
Scientific title
Comparing the Efficacy of Probiotic and Antibiotic Combination Therapy with Antibiotic Therapy Alone on the Recurrence of Bacterial Vaginosis
Public title
Comparing the Efficacy of Probiotic and Antibiotic Combination Therapy with Antibiotic Therapy Alone on the Recurrence of Bacterial Vaginosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women 18–45 years old Having bacterial vaginosis diagnosed according to Amsel's criteria (at least three of the following BV symptoms: Greyish white, thin, homogenous vaginal discharge, vaginal pH >4.5, positive amine test findings, and presence of clue cells (>20%) in a wet smear observed under microscopy) all cured with metronidazole
Exclusion criteria:
History of allergy against the study drug. Pregnant Lactating women Menopausal women History of bleeding from the genital tract of unknown etiology Women with malignancy of reproductive tract or any co-morbid condition like AIDS, diabetes, psychiatric illness Currently using any contraceptive method Patients using another oral or vaginal probiotic at the time of assessment or receiving antibiotic therapy for another reason
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 120
Actual sample size reached: 130
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized using the lottery method. Each tablet was sealed in a wrapper and by lottery method, will be given to each indivdual
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blinding would involve ensuring that the participants (pregnant women) and care provider are unaware of whether they are receiving the actual drug (antibiotic plus probiotic) or an antibiotic alone. This helps minimize bias and ensures that the results of the study are not influenced by the participants' or researchers' expectations or beliefs.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Institutional Ethical Review Board (IERB)
Street address
Nishtar hospital, Mutan
City
Multan
Postal code
66000
Approval date
2022-03-01, 1400/12/10
Ethics committee reference number
095

Health conditions studied

1

Description of health condition studied
Bacterial vaginosis
ICD-10 code
N76.0
ICD-10 code description
Acute vaginitis

Primary outcomes

1

Description
Recurrence of Bacterial Vagniosis
Timepoint
at 3 month
Method of measurement
Using Amsel Criteria (at least three of the following BV symptoms: Greyish white, thin, homogenous vaginal discharge, vaginal pH >4.5, positive amine test findings, and presence of clue cells (>20%) in a wet smear observed under microscopy)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: antibiotics and probiotics combined: In Group A, probiotics (Lactobacillus plantarum PBS067, Lactobacillus rhamnosus LRH020, and Bifidobacterium animalis lactis BL050) were administered once a day for 14 days following antibiotic treatment (Tab Metronidazole 400mg TDS for seven days).
Category
Treatment - Drugs

2

Description
Control group: Group B (Antibiotic plus placebo): A post-antibiotic therapy placebo (Dextrose-filled pill)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Gynae and Obs, Nishtar Hospital, Multan
Full name of responsible person
Dr. Saima Ashraf
Street address
Nishtar Hospital, Multan
City
Multan
Postal code
66000
Phone
+92 312 8443876
Email
saimashahzad35177@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
DME of Nishtar hospital
Full name of responsible person
Dr. Mehnaz Khakwani
Street address
Nishtar Hospital, Multan
City
Multan
Postal code
66000
Phone
+92 61 4702121
Email
nmu@edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
DME of Nishtar hospital
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
Nishtar Hospital, Multan
Full name of responsible person
Dr. Saima Ashraf
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Nishtar Hospital, Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 311 8443876
Email
saimashahzad35177@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
NISHTAR HOSPITAL, MULTAN
Full name of responsible person
Dr. Saima Ashraf
Position
ASSISTANT PROFESSOR
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Nishtar Hospital, Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 311 8443876
Email
saimashahzad35177@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
NISHTAR HOSPITAL, MULTAN
Full name of responsible person
Dr. Saima Ashraf
Position
ASSISTANT PROFESSOR
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Nishtar Hospital, Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 311 8443876
Email
saimashahzad35177@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
due to cultural reasons, patients usually hide personal data on individual basis
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Clinical study types, design, and Data statistics
When the data will become available and for how long
till the start of 2024, for lifelong
To whom data/document is available
all public
Under which criteria data/document could be used
only for citations
From where data/document is obtainable
google scholar and personal email
What processes are involved for a request to access data/document
request on personal email
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