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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250302064907N1

Enrollment

Registered

2025-05-04

Start date

2025-06-20

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic stem cell transplantation. ????? ??????? ??????

Interventions

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 pla

Eligibility

Sex/Gender

All

Age

2 Years to 18 Years

Inclusion criteria

Inclusion criteria: Children with acute leukemia who are undergoing hematopoietic stem cell transplantation Informed consent obtained through legal guardians Individuals aged over 2 years and under 18 years Children Indicated for Initiating Parenteral Nutrition

Exclusion criteria

Exclusion criteria: The presence of specific diseases, as well as kidney and liver failure Peanut and soy allergy Fish allergy Serum triglyceride levels exceeding 200 at baseline.

Design outcomes

Primary

Measure	Time frame
Fecal microbial species. Timepoint: Examination of stool samples for microbial species at the beginning of the study (before the intervention), on day 15, and on day 30 after the intervention. Method of measurement: Laboratory kit for detecting fecal microbial species.	—

Secondary

Measure	Time frame
Amount of fecal short-chain fatty acids. Timepoint: Before intervention_15 days, and 30 days after intervention. Method of measurement: High-performance liquid chromatography (HPLC).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactProf. Amir Ali Hamidieh

Tehran University of Medical Sciences

aahamidieh@sina.tums.ac.ir+98 21 6693 0024

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026