Determining the effect of the probiotic supplement on the rate of vaginal colonization of GBS in pregnant women with group B streptococcus
Design
A clinical trial with the control group, with parallel groups, double-blind, randomized, phase 3 on 64 pregnant women with group B streptococcus. Sealedenvelope software is used for randomization.
Settings and conduct
This study will evaluate the Familact effect on GBS in pregnant women referred to Al-Zahra Hospital. In the Intervention group, patients will receive 1capsule of 500 mg Familact for 1month. The supplement constituents 7strains. Familact is a probiotic from Zist Takhmir Company consisting of 109probiotic units. In the Control group, patients will receive 1capsule of placebo with the same smell and taste as Probiotic supplement for one 1month. Sampling was performed by the blocking randomization method. Women will be randomly assigned with 4and 6 block sizes with 1:1 allocation to the two groups of intervention and control. Double Blinding will be performed for participants and Researchers.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patient consent to participate, Pregnant women>18years of age who are diagnosed with GBS, Having a positive culture, Gestational age 36 weeks and less
Exclusion Criteria:Preeclampsia or gestational diabetes or other diseases, Termination of pregnancy<38 weeks, Absolute bed rest of the patient
Intervention groups
Intervention group: Patients will receive 1capsule of 500mg Familact for 1month. The supplement constituents 7strains. Familact is a probiotic from Zist Takhmir Company consisted of 109probiotic units. Control group: Patients will receive 1capsule of placebo with the same texture as a Probiotic supplement for 1month
Main outcome variables
Frequency of group B streptococcus at the end of one month
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211012052737N1
Registration date:2021-11-02, 1400/08/11
Registration timing:registered_while_recruiting
Last update:2021-11-02, 1400/08/11
Update count:0
Registration date
2021-11-02, 1400/08/11
Registrant information
Name
Elham Tooti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2086
Email address
drelhamtooty.inf@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of oral probiotics on vaginal Group B Streptococcal colonization rates on Group B Streptococcus (GBS)-positive pregnant women
Public title
The impact of oral probiotics on vaginal Group B Streptococcal colonization rates on Group B Streptococcus (GBS)-positive pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient consent to participate in this study
Pregnant women over 18 years of age who are diagnosed with GBS based on physical examination, clinical and laboratory signs.
Having a positive culture of vaginal / rectal secretions for group B streptococci
Gestational age 36 weeks and less
Exclusion criteria:
Preeclampsia or gestational diabetes or other diseases
Termination of pregnancy earlier than 38 weeks of gestation
Absolute bed rest of the patient
Taking antibiotics during the intervention and one week before it
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done before the start of the program by https://www.sealedenvelope.com considering 32 people in each group (2 groups of probiotic and control in 2 simple and complex strata) in 6 blocks. Any of them is placed in a separate envelope according to the list obtained from the software and it will be closed and provided to the third person. Patients' names will be registered by admission. If the patient comes and is qualifed، the envelope will be opened and based on the expected sequence, she will be treated.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and participants are blind in this study (double-blind). The Researcher does not know which participant is in the intervention or control group. The participant does not know whether he/ she is in the intervention or control group. Both groups will receive capsules with the same shape and color with different contents. Intervention and control capsules will be noted as A and B by a pharmacist unaware of the research and will be given to the researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences
Street address
hezar jrib
City
isfehan
Province
Isfehan
Postal code
4144444444
Approval date
2020-09-20, 1399/06/30
Ethics committee reference number
IR.MUI.MED.REC.1399.513
Health conditions studied
1
Description of health condition studied
Streptococcus group B in pregnant women
ICD-10 code
099.820
ICD-10 code description
Streptococcus B carrier state complicating pregnancy
Primary outcomes
1
Description
frequency of group B streptococcus
Timepoint
1 month after intervention
Method of measurement
Positive culture test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pregnant women will receive one 500 mg Familact capsule for 1 month. The supplement constituents 7 strains ( Lactobacillus Casei, Lactobacillus Rhamnosus, Streptococcus thermophiles, Bifidobacterium brevis, Lactobacillus acidophilus, Bifidobacterium lehman, Lactobacillus bulgaricus). Familact is from Zist Takhmir Company consisted of 109 probiotic units.
Category
Treatment - Other
2
Description
Control group: Pregnant women in the placebo group will get a placebo capsule daily for one month, which is similar in appearance to a probiotic capsule.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Elham Tooti
Street address
hezar jrib
City
Isfehan
Province
Isfehan
Postal code
4144444444
Phone
+98 31 3620 2086
Email
elentooty@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Nemat bakhsh
Street address
hezar jrib
City
Isfehan
Province
Isfehan
Postal code
4144444444
Phone
+98 31 3620 2086
Email
nematbakhsh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Elham Tooti
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Shohadaye Soffe, Alzahra Hospital
City
Esfahan
Province
Isfehan
Postal code
4144444444
Phone
+98 31 3620 2086
Fax
Email
drelhamtooty.inf@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham Tooti
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Shohadaye Soffe, Alzahra Hospital
City
Esfahan
Province
Isfehan
Postal code
4144444444
Phone
+98 31 3620 2086
Fax
Email
drelhamtooty.inf@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham Tooti
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Shohadaye Soffe, Alzahra Hospital
City
Esfahan
Province
Isfehan
Postal code
4144444444
Phone
+98 31 3620 2086
Fax
Email
drelhamtooty.inf@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