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IRCT20211226053529N1 IRCT 2021-12-31 Iran University of Medical Sciences Effect of Synbiotic on reducing insulin resistance in overweight or obese children The effect of Synbiotic on reducing insulin resistance in overweight or obese children 2021-12-22 anticipated 40 Complete https://irct.ir/trial/60929 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block randomization method is used with blocks of sizes six and four. The website https://www.sealedenvelope.com is used to create a randomization sequence. Each random sequence generated contains a unique code for concealment. The drug regimen is placed in envelopes according to random sequence, and after sealing it on the envelopes, the specific number created by the site is written and the envelopes are randomly placed in a box, Blinding description: This study is double-blinded: both the patient and the doctor are unaware of the type of medication. Method of blinding patients: Synbiotic supplement is in the form of sachets, placebo sachets are exactly similar to the appearance, taste and smell of Kidi Lact and (produced by Zist Takhmir Company). Physician blinding method: sealed envelopes created by the Company are provided to a researcher who does not interfere in choosing the type of drug. After entering the study and collecting their baseline information from the physician, the individuals send them to the researcher to get the medicine, and the researcher will give one of the envelopes to the patients, and then in the sheet that is kept with the researcher, it is specified that What medicine has each patient taken. 3 Obesity. Intervention 1: Intervention group: Children receive 1 sachet of probiotic daily (Kidi Lact, manufactured by Zist Takhmir Company, Iran) for 8 weeks. Intervention 2: Control group: Children received one placebo sachet (manufactured by Zist Takhmir Company, Iran) daily for 8 weeks. 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 There is no further information
public Rana Drodian
Zafar st, Aliasghar Children's Hospital
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6253 rohani.f@iums.ac.ir Iran University of Medical Sciences scientific Rana Drodian
Zafar st, Aliasghar Children's Hospital
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6253 dr.r.doroudian@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Age range between 4 -18 years Obese or overweight children: Obese children, children with a BMI of more than 95% and overweight children, children with a BMI between 85-95% Children with insulin resistance (HOMA-IR : > 2.5 = Positive for IR) 4 years 18 years Both Children who developed obesity following synromic disorder or endocrine disorders Physical disability Taking corticosteroids Treated with metformin Under special treatment or diet Acute pancreatitis History of allergies E66 Overweight and obesity Treatment - Drugs Placebo Intervention group: Children receive 1 sachet of probiotic daily (Kidi Lact, manufactured by Zist Takhmir Company, Iran) for 8 weeks. Control group: Children received one placebo sachet (manufactured by Zist Takhmir Company, Iran) daily for 8 weeks. Insulin Resistance level. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: HOMA-IR.Index (µU/ml). Iran University of Medical Sciences Approved 2021-11-21 Ethics committee of Iran University of Medical Sciences Hemmat Highway, Next to the Milad Tower Tehran Tehran Iran (Islamic Republic of)