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IRCT20260527069548N1 IRCT 2026-08-27 Ahvaz University of Medical Sciences The effect of Ostrovit Sodium Butyrate supplementation in children candidates for allogeneic hematopoietic stem cell transplantation HSCT 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 2026-10-23 anticipated 50 Recruiting https://irct.ir/trial/90430 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are randomly assigned to one of two intervention and control groups using a randomized block design, in which patients are classified according to age and BMI-Zscore (Stratified Randomized Block Design), Blinding description: In order to conduct this study in a double-blind manner, at the beginning of the study, the relevant set of bottles was coded as A and B by someone other than the researcher to ensure that the researcher and patients were unaware of the type of supplements received by each group. 1 Children undergoing allogeneic hematopoietic stem cell transplantation. Intervention 1: Intervention group: Eligible participants will be randomly assigned to either the intervention or control group after day 15 following allogeneic hematopoietic stem cell transplantation. The intervention will be administered for 12 weeks.Participants in the intervention group will receive one capsule containing 600 mg of sodium butyrate orally once daily. The investigational supplement is a plant-based microencapsulated/enteric-coated formulation manufactured by a company located in Poland. Each capsule contains 600 mg of sodium butyrate, corresponding to 180 mg of butyric acid. Hydroxypropyl methylcellulose (HPMC) is used as an excipient/filler. The formulation is designed to protect the active ingredient from the acidic gastric environment and facilitate its release in the lower gastrointestinal tract. The supplement will be administered orally once daily with an adequate amount of water, according to the study instructions. Each participant will receive the intervention for 12 weeks, equivalent to 84 days. The capsules will be dispensed in containers containing 30 capsules. A total of 90 capsules will be provided in three separate containers to cover the entire intervention period. Adherence will be assessed by counting the remaining capsules. Participants who consume less than 90% of the prescribed capsules will be excluded from the study analysis. To maintain blinding, bottles containing the active supplement and placebo will be coded as A and B by an individual who is independent of the research team before the initiation of the study. The allocation codes will remain concealed from both the investigators and participants until completion of data collection and analysis. Randomization will be performed using a stratified randomized block design, with stratification according to age and BMI . Intervention 2: Control group: Participants in the control group will receive one placebo capsule orally once daily for 12 weeks. The placebo will contain starch and will be manufactured by Takgene Company, Iran. The placebo capsules will be identical to the sodium butyrate capsules in terms of appearance, color, shape, odor, and packaging. Yes - There is a plan to make this available What will be shared: After the study is completed, the protocol and results will be published in the form of an article. When: One year after the start of the study To whom: Researchers working in academic and scientific institutions Conditions: If recognized with the protocol in line with diagnostic and therapeutic goals in the field of children Where to obtain: Dr. Ahmad Hosseini's email How to obtain: Given that the sampling period is estimated to be one year, data publication will be at least one year after the start of the study. Comments:
public Dr. Ahmad Hosseini
Ahvaz - Medical Sciences Boulevard - Jundishapur Medical Sciences
ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3314 0000 seyedahmadhosseini@yahoo.com Ahvaz University of Medical Sciences scientific Dr. Ahmad Hosseini
Ahvaz - Medical Sciences Boulevard - Jundishapur Medical Sciences
ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3314 0000 seyedahmadhosseini@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) 1- Children between the ages of 2-18 years with hematological malignancies who are candidates for allogeneic hematopoietic stem cell transplantation and refer to the Transplant Center of the Children's Medical Center Hospital. 2 years 18 years Both Having other chronic diseases (chronic intestinal inflammation, liver or kidney failure, celiac disease, etc.) Weekly intake of probiotic supplements during the past three months Patients who were hospitalized at the start of the study. Being on a diet or any specific dietary changes within the past three months Treatment - Drugs Treatment - Drugs Intervention group: Eligible participants will be randomly assigned to either the intervention or control group after day 15 following allogeneic hematopoietic stem cell transplantation. The intervention will be administered for 12 weeks.Participants in the intervention group will receive one capsule containing 600 mg of sodium butyrate orally once daily. The investigational supplement is a plant-based microencapsulated/enteric-coated formulation manufactured by a company located in Poland. Each capsule contains 600 mg of sodium butyrate, corresponding to 180 mg of butyric acid. Hydroxypropyl methylcellulose (HPMC) is used as an excipient/filler. The formulation is designed to protect the active ingredient from the acidic gastric environment and facilitate its release in the lower gastrointestinal tract. The supplement will be administered orally once daily with an adequate amount of water, according to the study instructions. Each participant will receive the intervention for 12 weeks, equivalent to 84 days. The capsules will be dispensed in containers containing 30 capsules. A total of 90 capsules will be provided in three separate containers to cover the entire intervention period. Adherence will be assessed by counting the remaining capsules. Participants who consume less than 90% of the prescribed capsules will be excluded from the study analysis. To maintain blinding, bottles containing the active supplement and placebo will be coded as A and B by an individual who is independent of the research team before the initiation of the study. The allocation codes will remain concealed from both the investigators and participants until completion of data collection and analysis. Randomization will be performed using a stratified randomized block design, with stratification according to age and BMI Control group: Participants in the control group will receive one placebo capsule orally once daily for 12 weeks. The placebo will contain starch and will be manufactured by Takgene Company, Iran. The placebo capsules will be identical to the sodium butyrate capsules in terms of appearance, color, shape, odor, and packaging. Firmicutes, Bacteroidetes,Proteobacteria. Timepoint: Before the start of the intervention and three months after the intervention. Method of measurement: 1 gram of each stool sample will be selected for extraction. Molecular analysis will be performed using RT-qPCR (real-time polymerase chain reaction) using the Light Cycler 480 system. Citrulline. Timepoint: Before the start of the intervention and three months after the intervention. Method of measurement: HPLC method. Zenolin. Timepoint: Before the start of the intervention and three months after the intervention. Method of measurement: Measurement by kit. Severity of aGVHD. Timepoint: Before the start of the intervention and three months after the intervention. Method of measurement: aGVHD will be reviewed and recorded based on international standard criteria including clinical grading according to the GVHD grading index system, such as the Glucksberg or NIH consensus criteria, after study by the consultant professor and pediatric oncology specialist (Dr. Hamidieh and Dr. Behfar). Severity of digestive symptoms (bloating, pain, abdominal distension, diarrhea, constipation). Timepoint: Before the start of the intervention and three months after the intervention. Method of measurement: By questionnaire. Number of hospitalizations. Timepoint: Before the start of the intervention and three months after the intervention. Method of measurement: By questionnaire. Length of hospital stay (days). Timepoint: Before the start of the intervention and three months after the intervention. Method of measurement: By questionnaire. Weight. Timepoint: Before the start of the intervention and three months after the intervention. Method of measurement: Via digital scale. Height. Timepoint: Before the start of the intervention and three months after the intervention. Method of measurement: Wall-mounted thermometer. BMI-Zscore. Timepoint: Before the start of the intervention and three months after the intervention. Method of measurement: CDC or WHO growth charts. Body fat mass. Timepoint: Before the start of the intervention and three months after the intervention. Method of measurement: Bioelectrical Impedance Analysis. Body muscle mass. Timepoint: Before the start of the intervention and three months after the intervention. Method of measurement: Bioelectrical Impedance Analysis. Upper arm circumference (MUAC). Timepoint: Before the start of the intervention and three months after the intervention. Method of measurement: Tape measure. Ahvaz University of Medical Sciences Approved 2026-04-25 Ethics Committee of Ahvaz University of Medical Sciences Ahvaz - Medical Sciences Boulevard - Jundishapur Medical Sciences ahvaz Khouzestan Iran (Islamic Republic of)