Investigating the Effect of Synbiotic Supplementation on Inflammatory Indices in Children with Sepsis Hospitalized in the Intensive Care Unit in comparison with placebo

Investigating the effect of synbiotic supplementation on inflammatory indices in children with sepsis hospitalized in the intensive care unit

A clinical trial with a control group, parallel-group, triple-blind, randomized, phase 1 study on 54 patients. Sealedenvelope site was used for randomization

Patients aged 1 month to 10 years with sepsis hospitalized or admitted to the pediatric intensive care unit of Akbar Mashhad Hospital. The intervention group will receive Kid Locket synbiotic product with a daily dose of 2 sachets and the control group will receive 2 placebo sachets for 7 days. The concentration of inflammatory factors (ESR, CRP, TNF α, IL6) on the seventh day and the duration of hospitalization, the mortality rate, the duration of ventilator connection and the need for antibiotic treatment will be compared in the two groups.

inclusion criteria : any patient admitted to the pediatric intensive care unit with a diagnosis of sepsis with the possibility of hospitalization for more than 4 days in the PICU, patients in the age group of 1 month to 10 years, parental consent to participate in the project. Conditions of non-entry: immunodeficiency or malignancy, people who are on steroid therapy or immunotherapy,Congenital malformations incompatible with life, previous gastrointestinal surgery in the last month, ulcerative colitis, short bowel syndrome.

The intervention group will receive Kidilact Synbiotic product containing 10 bacterial strains (produced by zisttakhmir Company) with a daily dose of 2 sachets and the control group will receive 2 placebo sachets (produced by zisttakhmir Company) for 7 days.

Interleukin 6 ؛C-reactive protein ؛Erythrocyte sedimentation rate؛ Tumor necrosis factor

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

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.

The data related to the demographic information of the people, the information of the biochemical tests of the people and the information related to the supplement used in the study will be at the disposal of Mashhad University of Medical Sciences as the organization under its supervision and in the comprehensive database of the University of Sciences. Mashhad Medical Center will be located.

The access period starts 6 months after the results are published.

The information will be available to the researchers and the industry upon the discretion and approval of all project partners.

The information will be available to the researchers and the industry upon the discretion and approval of all project partners.

To receive information, the email of the responsible author and the first author will be provided to people in the journal in which the project will be published, and with an explanation of the reason for the need to access the desired study, if approved and at the discretion of the project partners, access to the data , will be given. Corresponding author: Dr. Fatemeh Roudi Email address: RoudiF@mums.ac.ir Phone: 05131891509 First author: Ali Chamani Email address: chamaniA4012@mums.ac.ir Phone: 09021530646

By requesting by e-mail to the responsible author or the first author and explaining the reason for the need to access the desired study, the data access plan will be given upon approval and discretion of the colleagues.