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Study aim: Determination and Comparison of the Effects of a Parenteral High-Protein Diet Containing an Amino Acid Solution, Dextrose, and Soybean Oil-Based Lipid with SMOFlipid and Royal Jelly on the Composition of Intestinal Microbiota in Children with Acute Leukemia Following Hematopoietic Stem Cell Transplantation (HSCT) Design: Intervention Group 1: SMOFlipid and placebo; Intervention Group 2: SMOFlipid and royal jelly; Control Group: Intralipid and placebo. This is a controlled, double-blind, phase 3 clinical trial involving 30 patients who were randomized using block randomization. Settings and conduct: Study Location: Tehran Pediatric Medical Center Study; Population: Children with acute leukemia who are candidates for HSCT; Type of Blinding: Double-blind; Method of Blinding: Each lipid dose is completely wrapped in foil, ensuring that the type of lipid remains concealed. Royal jelly and placebo capsules are administered in identical forms, with the same taste and consistency. Participants/Inclusion and exclusion criteria: Inclusion criteria: Acute leukemia undergoing HSCT; informed consent; age over 2 and under 18 years; indication for starting parenteral nutrition. Exclusion criteria: presence of specific disease or renal/hepatic failure; allergy to peanut/soy; allergy to fish; serum triglyceride levels above 200 at the beginning of the study Intervention groups: Intervention Group 1: SMOFlipid and Placebo (intravenous lipid injection combined with oral intake of a capsule identical to royal jelly containing a placebo). Intervention Group 2: SMOFlipid and Royal Jelly (intravenous lipid injection combined with oral intake of royal jelly capsules). Control Group: Intralipid and Placebo (intravenous lipid injection combined with oral intake of a capsule identical to royal jelly containing a placebo). Main outcome variables: Fecal microbial species; Fecal microbial products (short-chain fatty acids)
IRCTID: IRCT20250302064907N1
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  2. The effect of N-acetyl cysteine in preventing the incidence and severity of mucositis in patients undergoing bone marrow transplantation
  3. Prophylactic administration of Natural Killer cells early after hematopoietic stem cell transplantation in adult patients with high-risk acute myeloid leukemia
  4. Investigating the safety and efficacy of active natural killer cell infusions in patients with MRD-positive Acute Lymphoblastic Leukemia after hematopoietic stem cell transplantation: a phase I/II trial
  5. Evaluation the effect of enteral Royal jelly supplementation compared to standard enteral nutrition on gut microbiota pattern and septic complication in critically ill patients
  6. The effects of royal jelly supplementation on inflammatory status, oxidative stress, mental health, cognitive function, disease severity and quality of life in patients with ischemic stroke
  7. Safety and efficacy of modified donor lymphocyte infusion (DLI) in reducing infection risk in adult patients with acute leukemia following allogeneic hematopoietic stem cell transplantation
  8. The effect of Ostrovit Sodium Butyrate supplementation on intestinal permeability and microbiota, anthropometric indices, complication and mortalility rate in children candidates for allogeneic hematopoietic stem cell transplantation: A randomized, double-blind clinical trial
  9. The Effect of royal jelly supplementation on serum antioxidants status, lipid profiles, insulin resistance and glucose level and inflammatory factors in type 2 diabetes
  10. Evaluation of prophilacticN-Acetylcysteine (NAC) in Poor Graft Function (PGF) and Prolonged Thrombocytopenia (PT) in haploidentical Haematopoietic stem cells transplantation (HSCT) patients: A phase 3, triple-blinded, randomized, placebo-controlled trial
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