NCT07515430

The Association Between Gut Microbiome Composition Signature and Cancer-related Symptoms in Children With Acute Lymphoblastic Leukemia

The Association Between Gut Microbiome Composition Signature and Cancer-related Symptoms in Children With Acute Lymphoblastic Leukemia: A Longitudinal Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 138 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective longitudinal investigation. Data on disease-related information, gut microbiota composition, cancer-related symptoms, dietary intake, and levels of pro-inflammatory cytokines, LPS were collected repeatedly at the following time points: before chemotherapy initiation, at the end of induction chemotherapy or Re-induction I, at 8 weeks after induction or re-induction therapy, at three months after induction or re-induction therapy, as well as weekly between chemotherapy initiation and the end of induction chemotherapy or Re-induction I. The aim is to explore the relationship between gut microbiota composition and cancer-related symptoms.

Detailed description

This study is a prospective longitudinal investigation. (1) Describe the composition characteristics and dynamic changes of the gut microbiota in children with ALL, assessed weekly from before chemotherapy initiation until the end of induction chemotherapy or Re-induction I, as well as at 8 weeks and three months after the completion of induction or re-induction therapy. (2) Describe the severity levels and dynamic changes of cancer-related symptoms in children with ALL, assessed weekly from before chemotherapy initiation until the end of induction chemotherapy or Re-induction I, as well as at 8 weeks and three months after the completion of induction or re-induction therapy. (3) Investigate the correlations between gut microbiota composition, lipopolysaccharide (LPS), inflammatory cytokines (IL-6, IL-1β, TNF-α), and serotonin (5-HT) with cancer-related symptoms in children with ALL, assessed at the time points specified in (1) and (2). (4) Explore the main factors influencing the characteristics of gut microbiota composition in children with ALL from baseline to three months after the completion of induction or re-induction therapy.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
OTHER	Questionnaires set	Planned to undergo a complete cycle of induction chemotherapy, with repeated collection of data including disease-related information, cancer-related symptoms, dietary records, and pro-inflammatory cytokine questionnaires. These data will be collected at the following time points: before the initiation of chemotherapy, upon completion of induction chemotherapy or Re-induction I, at 8 weeks post-induction or re-induction therapy, at three months post-induction or re-induction therapy, as well as weekly from the start of chemotherapy until the end of induction chemotherapy or Re-induction I.
OTHER	fecal sample collecting	Planned to undergo a complete cycle of induction chemotherapy, with repeated collection of fecal sample. These data will be collected at the following time points: before the initiation of chemotherapy, upon completion of induction chemotherapy or Re-induction I, at 8 weeks post-induction or re-induction therapy, at three months post-induction or re-induction therapy, as well as weekly from the start of chemotherapy until the end of induction chemotherapy or Re-induction I.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

2 sites across 1 country: China