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
Determining the effectiveness of adding probiotic supplements to standard treatment in the treatment process of pregnant women with COVID-19
Design
A clinical trial with control group, parallel groups, double-blind, randomized, phase3 will be performed on 80 patients. Randomization will be generated using a random generator program.
Settings and conduct
In this study, pregnant women with COVID19 admitted to Hospital are randomly assigned to two groups using a randomized 4block method. Random sequences are placed in closed envelopes in the "corona section". The patient and the outcome assessor do not know the nature of the codes (double-blind study).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women withCOVID-19 hospitalization in Hospital; positive PCR; Hospitalization on the day of admission; Onset of Covid symptoms up to5 days before admission to the study; Gestational age>12 weeks; Age≥16years; fever; respiratory rate≥24/ minute or oxygen saturation< 93or Pa2/ Fi2;Completion of informed consent form
Exclusion criteria: any obstetric problems, placental abruption; underlying diseases; chronic diseases and gastrointestinal disorders; History of receiving a probiotic supplement in the one week prior to enrollment
Intervention groups
The intervention group will receive Lactofem synbiotic capsules and the control group will receive placebo capsules 2per day for at least 7 days (and until hospitalization(.The course of the disease will be monitored by examining the clinical symptoms and blood tests.
Main outcome variables
Duration to the improvement of clinical and paraclinical symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080826001096N8
Registration date:2022-01-02, 1400/10/12
Registration timing:prospective
Last update:2022-01-02, 1400/10/12
Update count:0
Registration date
2022-01-02, 1400/10/12
Registrant information
Name
Seyede Hajar Sharami
Name of organization / entity
Guilan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
sharami@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
probiotic supplements in the treatment of pregnant women with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 16 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
committee of Guilan University of Medical Sciences
Street address
P.O.Box: 4144654839, Reproductive Health Research Center, Al-zahra Hospital, Guilan University of Medical Sciences, Namjoo Street, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4144654839
Approval date
2021-11-24, 1400/09/03
Ethics committee reference number
IR.GUMS.REC.1400.406
Health conditions studied
1
Description of health condition studied
Coronavirus disease in pregnancy
ICD-10 code
O98.5
ICD-10 code description
Other viral diseases complicating pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
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)
2
Description
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
Secondary outcomes
1
Description
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
2
Description
Body temperature
Timepoint
The first day of study and the day of discharge from the "corona ward"
Method of measurement
Thermometer
3
Description
Pulse rate
Timepoint
The first day of study and the day of discharge from the "corona ward"
Method of measurement
Clinical evaluation
4
Description
Respiratory rate
Timepoint
The first day of study and the day of discharge from the "corona ward"
Method of measurement
Clinical evaluation
5
Description
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
6
Description
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
7
Description
Duration of hospitalization
Timepoint
The first day of study and the day of discharge from the "corona ward"
Method of measurement
Patients' records
8
Description
Blood pressure
Timepoint
The first day of study and the day of discharge from the "corona ward"
Method of measurement
Patients' records
9
Description
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
10
Description
Mortality
Timepoint
At any time, based on the Patients' records
Method of measurement
Number, based on hospital records
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.