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Enrolling by Invitation

NCT Number: NCT07515430

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

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • (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.

Treatment and study plan

Questionnaires set

Other

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.

fecal sample collecting

Other

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.

Primary outcomes

  1. Cancer-related symptoms

    Time frame: 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 chemotherap

    The cancer-related symptoms will be assessed by Children's Therapy-Related Symptom Checklist (TRSC)

  2. Cancer-related symptoms

    Time frame: 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 chemotherap

    The cancer-related symptoms of sleep will be assessed by Pittsburgh Sleep Quality Index (PSQI)

  3. Cancer-related symptoms

    Time frame: 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 chemotherap

    The cancer-related symptoms of anxiety and depression will be assessed by Pediatric Patient-Reported Outcomes Measurement Information System (PROMIS)

  4. Gut microbiota signature

    Time frame: 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 chemotherap

    Gut microbiota signature will be assessed by fecal sample from children

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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