The Role of Gut Bacteria in Children with Leukemia - Effects on Cancer Development, Treatment Side Effects, and Immune System Recovery
Not Applicable
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
- Registration Number
- CTRI/2023/05/053016
- Lead Sponsor
- ady Tata Memorial Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
[1] Age: 3 -15 years
[2] New diagnosis of ALL
[3] Diagnosis of high risk ALL
Exclusion Criteria
[1] Receipt of antibiotics (intravenous or oral) within 7 days prior to study screening.
[2] Taking treatment elsewhere
[3] Not consenting
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare the microbiome in children with ALL with that of healthy siblings for association of gut microbiome composition with risk of developing ALL.Timepoint: At baseline (before start of treatment)
- Secondary Outcome Measures
Name Time Method a)Correlate with toxicity including incidence of mucositis and blood stream infections during treatment <br/ ><br>b)Determine changes in microbiome characteristics over time during treatment <br/ ><br>c)Document the prevalence of MDRO in the gut microbiome <br/ ><br>d)Correlate changes in microbiome with disease outcomes (e.g. post-induction MRD, 5-year EFS) <br/ ><br>Timepoint: 1. At baseline <br/ ><br>2. After 14 weeks (post consolidation chemo) <br/ ><br>3. After 29 weeks (post delayed intensification chemo) <br/ ><br>4. After 53 weeks (Post 2nd cycle of maintenace chemo)