IRCT20250302064907N1 IRCT 2025-05-04 Tehran University of Medical Sciences Studying the Effects of SMOFlipid and Royal Jelly on the Intestinal Microbiota of Children with Acute Leukemia Undergoing Hematopoietic Stem Cell Transplantation Comparison the effect of high protein parenteral nutrition containing amino acid solution, dextrose, and lipid based on soybean oil with SMOFlipid and royal jelly on gut microbiota composition in post hematopoietic stem cell transplantated acute leukemia children 2025-06-20 anticipated 30 Complete https://irct.ir/trial/82475 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization Double blocks, Sealed Envelope with Random Numbers The assignment of patients to each group and the distribution of envelopes will be at the sole discretion of the ward secretary. Randomization will be conducted using the block randomization method, which involves creating blocks of three. In this approach, one group is designated as A, the second as B, and the third as C. These letters are then arranged into blocks of three, resulting in six possible configurations for the arrangement of the letters. A random number between 1 and 6 will be generated by a calculator, and the blocks will be organized according to the order of the generated numbers. Based on this order, each patient entering the study will be assigned to one of the groups, following the sequence established within the blocks of three. Additionally, we will implement stratified randomization to ensure that patients are matched as closely as possible based on age and gender, thereby minimizing the risk of overmatching, Blinding description: The Intralipid and SMOFlipid bottles in the pharmacy will initially be covered with aluminum foil, ensuring that only the pharmacy manager is aware of the distinction between them. The group receiving royal jelly is positioned opposite the control groups, both of which will receive SMOFlipid, while the group receiving Intralipid will also be administered a placebo. The company that manufactures the royal jelly capsules produces identical capsules that match the taste and consistency of the placebo. Neither the principal investigator nor the patients will know which type of product they are using. 3 Hematopoietic stem cell transplantation. Intervention 1: Intervention group1: SMOFlipid+Placebo. Intravenous injection of SMOFlipid (Fresenius Kabi Co.,) at a dose of 0.5 to 1 gram per kg for a maximum of 10 days + oral administration of placebo in the form of capsules with a shape, taste, and consistency similar to royal jelly manufactured by Marine Co., 1000 mg capsules daily for 10 days. Intervention 2: Intervention group2: SMOFlipid + Royal jelly. Intravenous injection of SMOFlipid (Fresenius Kabi Co.,) at a dose of 0.5 to 1 gram per day for a maximum of 10 days + oral intake of royal jelly capsules manufactured by Marine Co., 1000 mg capsules daily for 10 days. Intervention 3: Control group: Intralipid + Placebo. Intravenous injection of Intralipid (Fresenius Kabi Co.,) at a dose of 0.5 to 1 gram per kg for a maximum of 10 days + oral administration of placebo in the form of capsules with a shape, taste, and consistency similar to royal jelly manufactured by Marine Co., 1000 mg capsules daily for 10 days. Yes - There is a plan to make this available What will be shared: The data related to predefined outcome will be provided as an SPSS file that does not include any identifying information about the patients. When: The access period begins six months after the results are published. To whom: Interested doctors, researchers and students Conditions: Sending the request via email. Where to obtain: Melika Hajimohammadebrahim-Ketabforoush; ketabforoshm@gmail.com How to obtain: The access period begins six months after the results are published, If the applicant is eligible. Comments: