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IRCT20211012052737N1 IRCT 2021-11-02 Esfahan University of Medical Sciences The impact of oral probiotics on vaginal Group B Streptococcal colonization rates on Group B Streptococcus (GBS)-positive pregnant women The impact of oral probiotics on vaginal Group B Streptococcal colonization rates on Group B Streptococcus (GBS)-positive pregnant women 2021-10-23 anticipated 64 Complete https://irct.ir/trial/59318 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Streptococcus group B in pregnant women. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is Considering ethical issues
public Elham Tooti
Shohadaye Soffe, Alzahra Hospital
Esfahan Iran (Islamic Republic of) 4144444444 +98 31 3620 2086 drelhamtooty.inf@gmail.com Esfahan University of Medical Sciences scientific Elham Tooti
Shohadaye Soffe, Alzahra Hospital
Esfahan Iran (Islamic Republic of) 4144444444 +98 31 3620 2086 drelhamtooty.inf@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Female 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 099.820 Streptococcus B carrier state complicating pregnancy Treatment - Other Treatment - Other 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. 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. Frequency of group B streptococcus. Timepoint: 1 month after intervention. Method of measurement: Positive culture test. Esfahan University of Medical Sciences Approved 2020-09-20 Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences hezar jrib isfehan Isfehan Iran (Islamic Republic of)