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NCT07515430Enrolling by invitation

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

Source: ClinicalTrials.gov · Last updated 7 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
138 (estimated)
First submitted
31 Mar 2026
Start date
1 Feb 2026
Primary completion date
1 Dec 2026
Lead sponsor
Sun Yat-sen University
NCT number
NCT07515430

What you commit to

  • Study type: Observational
  • Planned participants: 138
  • From 1 Feb 2026 to the primary completion date, 1 Dec 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • (2) Previous treatment with probiotics or fecal microbiota transplantation.

Other illness

  • \- (1) Presence of gastrointestinal diseases (e.g., ulcerative colitis, Crohn's disease, irritable bowel syndrome, etc.) or recent gastrointestinal surgery.

Who the study is looking for

  • 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.

Age in the registry: 5 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
the First Affiliated Hospital of Sun Yat-sen University
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Sun Yat-sen Memorial Hospital, Sun Yat-sen University; The First Affiliated Hospital of Sun Yat-sen University
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.