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
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).
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
Public title
Studying the Effects of SMOFlipid and Royal Jelly on the Intestinal Microbiota of Children with Acute Leukemia Undergoing Hematopoietic Stem Cell Transplantation
Purpose
Treatment
Inclusion/Exclusion 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:
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.
Age
From 2 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No. 62, Children’s Medical Center, Gharib avenue
City
Tehran
Province
Tehran
Postal code
02166948444
Approval date
2024-06-16, 1403/03/27
Ethics committee reference number
IR.TUMS.CHMC.REC.1403.075
Health conditions studied
1
Description of health condition studied
Hematopoietic stem cell transplantation
ICD-10 code
تغذیه
ICD-10 code description
پیوند سلولهای بنیادی
Primary outcomes
1
Description
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 outcomes
1
Description
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)
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
3
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Prof. Amir Ali Hamidieh
Street address
No. 62, Children's Medical Center, Next to Imam Khomeini Hospital, Dr. Mohammad Gharib Ave., End of Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 0024
Email
cmcpr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ramin Kordi
Street address
6th Floor, Vice President for Research and Technology, Central University Organization, corner of Qods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Amir Ali Hamidieh
Position
Full Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
No. 62, Children's Medical Center, Next to Imam Khomeini Hospital, Dr. Mohammad Gharib Ave., End of Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 0024
Email
aahamidieh@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Amir Ali Hamidieh
Position
Full Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
No. 62, Children's Medical Center, Next to Imam Khomeini Hospital, Dr. Mohammad Gharib Ave., End of Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 0024
Email
aahamidieh@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Amir Ali Hamidieh
Position
Full Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Hematology and Oncology Specialist - Hematopoietic Stem Cell Transplantation
Street address
No. 62, Children's Medical Center, Next to Imam Khomeini Hospital, Dr. Mohammad Gharib Ave., End of Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 0024
Email
aahamidieh@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
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 data will become available and for how long
The access period begins six months after the results are published.