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IRCT20230523058266N1 IRCT 2023-10-30 Vice President of Research and Technology, Mashhad University of Medical Sciences Investigating the Effect of Synbiotics on Inflammatory Indicators Investigating the Effect of Synbiotic Supplementation on Inflammatory Indices in Children with Sepsis Hospitalized in the Intensive Care Unit in comparison with placebo 2023-11-22 anticipated 27 Complete https://irct.ir/trial/71397 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Blocking using blocks of 4 and 6 Using the site sealedenvelope Synbiotics or placebos are packaged as a solution that looks, smells, and tastes the same in containers that look the same. The synbiotic or placebo is packaged in opaque packages with a random allocation number on it. Allocation of random number and preparation of packages containing synbiotic or placebo will be done by a person not involved in patient registration, data collection, data entry and analysis, Blinding description: Participant blinding: Due to the administration of a placebo with the same shape, taste and smell as the synbiotic supplement, the patient will be blinded to the treatment itself. Data analyzer: due to the use of the site and random block to allocate the intervention or placebo, the data analyzer will be blinded to the intervention. Researcher, clinical outcome assessor and clinical caregiver: due to the use of the site and random block for allocating intervention or placebo, the data analyzer will be blinded to the intervention. 3 Sepsis. Intervention 1: Intervention group:Kidilact synbiotic supplement containing 10 strains of bacteria produced by zisttakhmir company with a dose of 2 sachets daily for 7 days. Intervention 2: Control group: Control group: Placebo from zisttakhmir 2 sachets daily for 7 days. 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 At the end of the study, a decision will be made based on the discretion of the participating researchers.
public Fatemeh Roudi
East door of university campus, Azadi square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3189 1509 RoudiF@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh Roudi
East door of university campus, Azadi square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3189 1509 RoudiF@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Any Patient admitted to the Pediatric Intensive Care Unit with a Diagnosis of Sepsis and Possibility of Hospitalization for more than 4 Days in the PICU children aged 1 month to 10 years consent of parent to participation of their children to study 1 month 10 years Both Immunodeficiency or Malignancy steroid Therapy or Immunotherapy Congenital Abnormalities Incompatible with life Previous Gastrointestinal Surgery in the last month Ulcerative Colitis Short Bowel Syndrome A41.9 Sepsis, unspecified organism Treatment - Drugs Placebo Intervention group:Kidilact synbiotic supplement containing 10 strains of bacteria produced by zisttakhmir company with a dose of 2 sachets daily for 7 days Control group: Control group: Placebo from zisttakhmir 2 sachets daily for 7 days Interleukin-6. Timepoint: The beginning of the study (before the start of the intervention) and the 7th day after the start of taking the synbiotic supplement. Method of measurement: Interleukin 6 ELISA kit. C reactive protien. Timepoint: The beginning of the study (before the start of the intervention), 7 days after the start of taking the synbiotic supplement. Method of measurement: Measurement of serum levels. Tumor necrosis factor. Timepoint: The beginning of the study (before the start of the intervention), 7 days after the start of taking the synbiotic supplement. Method of measurement: Measurement of serum levels. Erythrocyte sedimentation rate. Timepoint: The beginning of the study (before the start of the intervention), 7 days after the start of taking the synbiotic supplement. Method of measurement: Measurement of serum levels. Vice President of Research and Technology, Mashhad University of Medical Sciences Approved 2023-09-19 Ethics committee of Mashhad University of Medical Sciences Azadi square, Mashhad, Khorasan Razavi Mashhad Razavi Khorasan Iran (Islamic Republic of)