Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fecal sample collecting | Other | — | UNRESOLVED |
| Questionnaires set | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Questionnaires assessed children with acute lymphoblastic leukemia
- description
- 1. 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. 2. 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)\*. 3. Conscious and capable of answering questions. 4. Voluntarily agree to participate in the study. 5. Planned to undergo a full cycle of induction chemotherapy.
- interventionNames
- Other: Questionnaires set
- Other: fecal sample collecting
Primary outcomes (4)
- measure
- Cancer-related symptoms
- timeFrame
- 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
- description
- The cancer-related symptoms will be assessed by Children's Therapy-Related Symptom Checklist (TRSC)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. 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)\*. 3. Conscious and capable of answering questions. 4. Voluntarily agree to participate in the study. 5. 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.
References
Publications (0)
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