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IRCT20080826001096N8 IRCT 2022-01-02 Rasht University of Medical Sciences probiotic supplements in the treatment of pregnant women with COVID-19 Evaluating the effectiveness of adding probiotic supplements to standard treatment in the treatment process of pregnant women with COVID-19: a double-blind randomized clinical trial 2022-01-05 anticipated 80 Complete https://irct.ir/trial/60503 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, random sequences will be generated using a random generator program. Based on the random block method and considering the quadruple blocks, a table with 20 rows (blocks) and each block with 4 sections (each section including A and B) will be produced for 80 pregnant women with COVID-19. After generating the list, each person will be assigned a unique code and the person will be identified with this code during the study. After all the numbers are placed in the blocks, the people who had the number in house A will receive the package with the code A and the people who had the number in the house B will receive the package with the code B.Allocation Concealment will be done using sealed envelopes (SNOSE), Blinding description: The double-blind clinical trial study will be performed using sealed envelopes (SNOSE). Based on the sample size of the research, several aluminum envelopes will be prepared and each of the random sequences created on a registered card and the cards will be placed in the envelopes respectively. In order to maintain a random sequence, the envelopes will be numbered in the same way on the outer surface. Finally, the envelope lid is glued and placed in a box, respectively. At the beginning of the intervention, the envelopes are opened in order and the assigned group of the participant is revealed. During the patient's hospital stay, due to the cold chain in Lactofem synbiotics, the package containing each patient's medication is stored in the Corona's refrigerator. The study was double-blind so that patients and outcome assessors were unaware of the status of the two study groups. 3 Coronavirus disease in pregnancy. Intervention 1: The intervention group (Probiotics+standard care treatment)will receive Lactofem synbiotic capsules (prepared by Zist-takhmir Company) twice daily after meals for at least 7 days until hospitalization. Each Lactofem capsule contains 500 mg of 4 strains of probiotic lactobacilli including Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus fementum, Lactobacillus gasseri and 38.5 mg of prebiotic substances including fructoo oligosaccharides. Probiotics are safe to take during pregnancy, and some pregnant women are usually prescribed 1-2 capsules daily to relieve constipation, prevent gestational diabetes, and reduce the risk of allergies in infants.The patient is visited by an infectious disease specialist (one of the project researchers). The course of the disease will be monitored by the research team by reviewing and comparing clinical symptoms and test results (Includes PCR and blood tests including CRP, CBC- diff, WBC, Platelet, lymph, ESR, CPK LDH)during the time of hospitalization in the corona ward. Intervention 2: Control group: (placebo+standard care treatment) will receive two placebo capsules (prepared by Zist-takhmir company) daily after meals for at least 7 days until hospitalization. Placebo is quite similar to a probiotic supplement in shape, color, odor, size and packaging, even the fillers or excipients available. The only difference is the absence of Lactobacillus and fructo oligosaccharide strains in placebo.In both groups, the patient's routine management is entirely the responsibility of the medical staff. Patients are also provided with a telephone number to ask the researcher any questions about the supplement or study or any possible side effects. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is En There is no plan to publish participants' information files.
public Dr. Seyedeh Hajar sharami
Al-Zahra Hospital, Namjoo Ave., Rasht, Guilan, IRAN
Rasht Iran (Islamic Republic of) 54839 -41446 +98 13 3336 9224 sharami@gums.ac.ir Rasht University of Medical Sciences scientific Dr. Seyedeh Hajar sharami
Al-Zahra Hospital, Namjoo Ave., Rasht, Guilan, IRAN
Rasht Iran (Islamic Republic of) 54839 -41446 +98 13 3336 9224 sharami@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Pregnant women with mild / moderate COVID-19 hospitalization in Al-Zahra Hospital in Rasht Diagnosis based on a positive PCR or antigen test results Hospitalization on the day of admission Onset of Covid symptoms up to 5 days before admission to the study Gestational age>12 weeks Age≥ 16 years fever (oral temperature ≥37.2 ° C) Having at least one of the criteria of respiratory rate≥24 per minute or oxygen saturation < 93 (without oxygen) Pa2 / Fi2 Completion of informed consent form 16 years no limit Female Existence of any obstetric problems such as premature rupture of the amniotic membrane, placental abruption History of receiving probiotic supplement for up to one week before enrollment Presence of underlying diseases and gastrointestinal disorders such as IBD Presence chronic diseases under treatment (such as asthma and allergies, heart failure) and acquired or congenital immunodeficiencies O98.5 Other viral diseases complicating pregnancy, childbirth and the puerperium Treatment - Drugs Placebo The intervention group (Probiotics+standard care treatment)will receive Lactofem synbiotic capsules (prepared by Zist-takhmir Company) twice daily after meals for at least 7 days until hospitalization. Each Lactofem capsule contains 500 mg of 4 strains of probiotic lactobacilli including Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus fementum, Lactobacillus gasseri and 38.5 mg of prebiotic substances including fructoo oligosaccharides. Probiotics are safe to take during pregnancy, and some pregnant women are usually prescribed 1-2 capsules daily to relieve constipation, prevent gestational diabetes, and reduce the risk of allergies in infants.The patient is visited by an infectious disease specialist (one of the project researchers). The course of the disease will be monitored by the research team by reviewing and comparing clinical symptoms and test results (Includes PCR and blood tests including CRP, CBC- diff, WBC, Platelet, lymph, ESR, CPK LDH)during the time of hospitalization in the corona ward. Control group: (placebo+standard care treatment) will receive two placebo capsules (prepared by Zist-takhmir company) daily after meals for at least 7 days until hospitalization. Placebo is quite similar to a probiotic supplement in shape, color, odor, size and packaging, even the fillers or excipients available. The only difference is the absence of Lactobacillus and fructo oligosaccharide strains in placebo.In both groups, the patient's routine management is entirely the responsibility of the medical staff. Patients are also provided with a telephone number to ask the researcher any questions about the supplement or study or any possible side effects. Duration from the start of the study until the improvement of clinical symptoms. Timepoint: The first day of study and the day of discharge from the "corona ward". Method of measurement: Clinical examination (using patient record). Duration from the start of the study until the improvement of paraclinical symptoms. Timepoint: The first day of study and the day of discharge from the "corona ward". Method of measurement: using patient record. Blood Oxygen Saturation Percentage (SPO2). Timepoint: The first day of study and the day of discharge from the "corona ward". Method of measurement: Pulse oximeter device. Body temperature. Timepoint: The first day of study and the day of discharge from the "corona ward". Method of measurement: Thermometer. Pulse rate. Timepoint: The first day of study and the day of discharge from the "corona ward". Method of measurement: Clinical evaluation. Respiratory rate. Timepoint: The first day of study and the day of discharge from the "corona ward". Method of measurement: Clinical evaluation. Radiological changes. Timepoint: The day of discharge from the corona ward or earlier at the discretion of the research team. Method of measurement: Percentage of lung involvement in plain or CT scan of the chest. Cough. Timepoint: The first day of study and the day of discharge from the "corona ward". Method of measurement: Clinical evaluation by a specialist physician member of the research team. Duration of hospitalization. Timepoint: The first day of study and the day of discharge from the "corona ward". Method of measurement: Patients' records. Blood pressure. Timepoint: The first day of study and the day of discharge from the "corona ward". Method of measurement: Patients' records. Serious side effects. Timepoint: At any time from the start of the study until the day of discharge from the corona. Method of measurement: Clinical evaluation. Mortality. Timepoint: At any time, based on the Patients' records. Method of measurement: Number, based on hospital records. Rasht University of Medical Sciences Approved 2021-11-24 committee of Guilan University of Medical Sciences P.O.Box: 4144654839, Reproductive Health Research Center, Al-zahra Hospital, Guilan University of Medical Sciences, Namjoo Street, Rasht, Iran Rasht Guilan Iran (Islamic Republic of)