الفهرس 
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Abstract
H
uman microbiota has emerged as an area of utmost interest, as many studies have highlighted its impact on health and diseases. It mainly consists of Bifidobacterium spp. and Faecalibacterium spp. for children, while it mainly consists of Bacteroides spp. for adults.
Since several factors such as genetic, environmental, and lifestyle can influence microbial constitutions, these factors along with gut microbiota should be evaluated as integrated for cancer progress.
This study aimed to:
Primary objective:
• Assessment of the safety of curcumin in children with acute lymphoblastic leukemia patients (ALL) in maintenance phase of chemotherapy through the assessment of the any reported adverse event (AE).
Secondary objective:
• Assessment of whether the curcumin had a protective effect on gut microbiota in children with ALL.
• Assessment of whether the gut microbiota can be used for predicting therapy-related complications (as infections and diarrhea).
This study was a single-center, open-label prospective randomized controlled clinical trial conducted at the Pediatric Hematology Oncology department of Ain Shams University Hospitals in Cairo, Egypt. The study recruited all patients who diagnosed with acute lymphoblastic leukemia (ALL) from day zero of presentation, were randomized between intervention group and SOC group to be followed up after induction and receiving one group to curcumin. The primary objective was to assess the tolerability of curcumin in pediatric patients with ALL.
In this study, the mean age at presentation showed a no significant difference from 7.80 ± 2.81 years in the SOC group to 7.63 ± 2.38 years in the intervention group. Urban residence slightly outnumbered rural residence among all patients (53.3% urban vs. 46.7% rural). Consanguinity rates were moderately positive in both groups (40%), with no significant difference observed. Similarly, family history of malignancy was comparable between groups, noted in 33.3% of patients in each group.
In this study, initial symptoms at diagnosis were similar between groups, with bony aches being most common, followed by fever and enlarged lymph nodes. At diagnosis, lymph node enlargement was predominant, along with organomegaly. In the intervention group, there was notable improvement over time, showing decreased prevalence of lymph node enlargement, organomegaly at various stages of the study.
Regarding anthropometric measurements in the current study, there was no significant difference between both group at diagnosis, after induction (maintenance phase) and after thirty days of curcumin, likewise STAMP score there was no difference between both group at different time of study
On the other hand, there was significant increase in weight, height, fat mass and body water in SOC group at different time of the study, also better screening of malnutrition (STAMP score) with p value 0.017, <0.001, 0.010, 0.014, <0.001 respectively.
With same results in intervention group at different time of study, there was significant increase in weight, height, fat mass, body water and they were better in malnutrition screening (STAMP score) with p value 0.001, <0.001, 0.004, 0.014, <0.001 respectively.
Laboratory findings initially showed no significant differences; however, after induction of chemotherapy, platelet counts were significantly higher in the intervention group. After thirty days of curcumin, the intervention group exhibited significantly higher total protein and albumin levels. Throughout the study, the intervention group showed significantly higher hemoglobin, mean corpuscular volume (MCV), platelet count, and albumin levels, along with significantly lower white blood cell and lymphocyte counts.
In the study, microbiota counts did not significantly differ between groups at diagnosis or after induction phase of chemotherapy, but after thirty days of curcumin treatment, the intervention group exhibited significantly higher microbiota counts compared to the standard of care (SOC) group. Within the intervention group, microbiota counts were consistently higher at various study time points. Regarding antibiotic and antifungal use, no significant differences were observed between groups at diagnosis or after induction phases. However, after thirty days of curcumin treatment, the SOC group had significantly higher usage of levofloxacin, vancomycin, and meropenem, while the intervention group showed significantly higher use of co-trimoxazole. Throughout the study, the intervention group had significantly lower use of levofloxacin, vancomycin, meropenem, nystatin, fluconazole, and voriconazole, but significantly higher use of co-trimoxazole compared to the SOC group.
Complications at diagnosis were significantly more frequent in the standard of care (SOC) group compared to the intervention group, with a higher incidence of febrile neutropenia versus chemotoxicity in both groups. Within the intervention group, 53.3% of patients experienced side effects from curcumin, with abdominal pain (40.0%) and nausea (13.3%) being the most common. After thirty days, there were no significant differences in outcomes between the two groups, with remission being the most prevalent outcome, followed by relapse and mortality.