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IRCT20210531051459N1 IRCT 2021-10-02 Mashhad University of Medical Sciences The effect of synbiotic in hospitalized covid-19 patients The effect of Lactocare synbiotic on clinical manifestations, inflammatory and non-inflammatory markers in hospitalized covid-19 patients 2021-09-27 anticipated 60 Complete https://irct.ir/trial/56744 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization type: Block Randomization unit: individual Randomization tool: Random number table using www.sealedenvelope.com How to create a random sequence: At www.sealedenvelope.com, the randomization section, after selecting create a list, specifies the number of groups, block sizes and list length, and accordingly, presents the list randomization. Allocation Concealment: Sealed envelopes, Blinding description: In this study, participants did not know the type of treatment they received. Also, patient clinicians, physicians, and outcome assessors are unaware of how patients are grouped and use medication or placebo. 3 COVID-19. Intervention 1: Intervention group: In the intervention group, hospitalized patients with Covid 19, in addition to standard treatment (Remdesivier, and glucocorticoids such as dexamethasone, methylprednisolone, and prednisolone), take two supplements of Lactocarb synobiotic daily after meals for 14 days. Lactocare capsules contains beneficial and safe bacterial strains along with prebiotic fructooligosaccharide. Lactocar capsule made by Zist Takhmir Company is gluten free and its CFU is 10^9. Intervention 2: Control group: In the control group (placebo), hospitalized patients with Covid 19 in addition to standard treatment (Remdesivier, and glucocorticoids such as dexamethasone, methylprednisolone, and prednisolone), take two placebo daily after meals for 14 days. The placebo is exactly the same color, shape, weight, and packaging as the Lactocare capsule. Placebo capsules are also purchased from Zist Takhmir Company. Yes - There is a plan to make this available What will be shared: The potential data can be shared after unidentified individuals. When: Access period starts 9 months after the published results To whom: The data will be available to researchers working in academic and scientific institutions. Conditions: The use of data and its analysis is allowed by mentioning the source. Where to obtain: Email the author of the article to receive the data. How to obtain: The processes that researcher who request data go through will include a letter of request from the person, a letter of request from the center or university of origin, and acceptance of the destination university to receive the information. Comments:
public Mona Kabiri
Clinical Research Development Unit, First Floor, Narjes building, Ghaem hospital, Ahmad Abad Ave.
Mashhad Iran (Islamic Republic of) ٩٩١٩٩-٩١٧۶۶ +98 51 3841 7403 kabirimn@mums.ac.ir Mashhad University of Medical Sciences scientific Mona Kabiri
Clinical Research Development Unit, First Floor, Narjes building, Ghaem hospital, Ahmad Abad Ave.
Mashhad Iran (Islamic Republic of) ٩٩١٩٩-٩١٧۶۶ +98 51 3841 7403 Kabirimn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Hospitalized patients with definitive diagnosis of Covid 19 using PCR or CT scan Conscious consent to participate in the study Age category 18 years and above 18 years no limit Both Acute pancreatitis Pregnancy and lactation Having autoimmune diseases and taking immunosuppressants or drugs used to reject transplants Taking supplements containing probiotics and prebiotics in the last three months Hospitalization in the ICU Patients treated with herbal medicines or other traditional medicine methods Dialysis patients Having a history of allergies to synbiotics Dissatisfaction with participating in the study U07.1 U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, hospitalized patients with Covid 19, in addition to standard treatment (Remdesivier, and glucocorticoids such as dexamethasone, methylprednisolone, and prednisolone), take two supplements of Lactocarb synobiotic daily after meals for 14 days. Lactocare capsules contains beneficial and safe bacterial strains along with prebiotic fructooligosaccharide. Lactocar capsule made by Zist Takhmir Company is gluten free and its CFU is 10^9. Control group: In the control group (placebo), hospitalized patients with Covid 19 in addition to standard treatment (Remdesivier, and glucocorticoids such as dexamethasone, methylprednisolone, and prednisolone), take two placebo daily after meals for 14 days. The placebo is exactly the same color, shape, weight, and packaging as the Lactocare capsule. Placebo capsules are also purchased from Zist Takhmir Company. The level of CRP inflammatory marker. Timepoint: At the beginning of the study and fourteen days after taking the capsule. Method of measurement: Blood test. The level of IL-6 inflammatory cytokine. Timepoint: At the beginning of the study and fourteen days after taking the capsule. Method of measurement: ELISA. ESR level. Timepoint: At the beginning of the study and fourteen days after taking the capsule. Method of measurement: Blood test. ALT level. Timepoint: At the beginning of the study and fourteen days after taking the capsule. Method of measurement: Blood test. AST level. Timepoint: At the beginning of the study and fourteen days after taking the capsule. Method of measurement: Blood test. ALP level. Timepoint: At the beginning of the study and fourteen days after taking the capsule. Method of measurement: Blood test. Creatinine level. Timepoint: At the beginning of the study and fourteen days after taking the capsule. Method of measurement: Blood test. Complete Blood Count (CBC). Timepoint: At the beginning of the study and fourteen days after taking the capsule. Method of measurement: Blood test. Cough. Timepoint: Daily (first day to fourteenth day of intervention). Method of measurement: Clinical check up. Fever. Timepoint: Daily (first day to fourteenth day of intervention). Method of measurement: Clinical check up. Breathing rate. Timepoint: Daily (first day to fourteenth day of intervention). Method of measurement: Clinical check up (number of breaths per minute). Sore throat. Timepoint: Daily (first day to fourteenth day of intervention). Method of measurement: Clinical check up. Generalized body pain. Timepoint: Daily (first day to fourteenth day of intervention). Method of measurement: Clinical check up. Dyspnea. Timepoint: Daily (first day to fourteenth day of intervention). Method of measurement: Clinical check up. SPO2. Timepoint: Daily (first day to fourteenth day of intervention). Method of measurement: Clinical check up. Weakness and lethargy. Timepoint: Daily (first day to fourteenth day of intervention). Method of measurement: Clinical check up. Stomach pain. Timepoint: Daily (first day to fourteenth day of intervention). Method of measurement: Clinical check up. Chest pain. Timepoint: Daily (first day to fourteenth day of intervention). Method of measurement: Clinical check up. Gastrointestinal symptoms (diarrhea, vomiting and nausea). Timepoint: Daily (first day to fourteenth day of intervention). Method of measurement: Clinical check up. Mashhad University of Medical Sciences Approved 2021-08-03 Ethics committee of Mashhad University of Medical Sciences Ghaem Hospital, Ahmad Abad Ave., Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)