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

Enrolling by invitation

Conditions studied: Acute Lymphoblastic Leukemia

In brief

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.

Key facts

Study ID

NCT07515430

Run by

Sun Yat-sen University

People needed

138

Starts

2026-02-01

Expected to finish

2026-12-01

Last updated by the study team

2026-04-07

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged between 5 and 18 years; considering that children over 5 are able to cooperate with the survey, the age range for this study is limited to 5-18 years.
• Confirmed diagnosis of ALL according to the MICM (morphology, immunology, cytogenetics, and molecular) criteria, following the *South China Children's Acute Lymphoblastic Leukemia Treatment Collaborative Group 2023 Protocol (SCCCG-ALL-2023)*.
• Conscious and capable of answering questions.
• Voluntarily agree to participate in the study.
• Planned to undergo a full cycle of induction chemotherapy.

You may not qualify if…

• (1) Presence of gastrointestinal diseases (e.g., ulcerative colitis, Crohn's disease, irritable bowel syndrome, etc.) or recent gastrointestinal surgery.
• (2) Previous treatment with probiotics or fecal microbiota transplantation.

Where it is running

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University; The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China
• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China

Full record on ClinicalTrials.gov

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