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Gut Health in Children With Cancer

NCT06899581 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-03-28

No results posted yet for this study

Summary

The purpose of this study is to observe the impact leukaemia treatment has on gut health (microbiomes) and how quickly the gut health recovers after leukamia treatment. The gut microbiome has a number of important functions not only in the gut but within the whole body. Changes to your child's nutritional status throughout treatment may affect how well they recover from treatment. This study will monitor the impact of feeding and nutrition on nutritional status and gut health in young people undergoing treatment for leukaemia. The measurements needed to observe nutritional and gut microbiomes will occur when your child attends their routine medical appointments at Great Ormond Street Hospital.

Medical treatment uses chemicals to kill leukaemia cells. The type of medications used in the treatment of leukaemia can damage the gut resulting in inflammation call mucositis. This stops the gut from working and sometimes nutrition has to be provided via a feeding tube or intravenous. Chemotherapy, mucositis and intravenous nutrition all have an impact on the gut. Little is know how the gut health recovers after treatment for leukaemia. This will be the first study to specifically monitor the impact of feeding and nutritional on gut health in children undergoing treatment for leukaemia.

By understanding what changes are occurring to your child's nutritional status and gut halth during treatment and during recovery will help to develop guidelines for healthcare professionals to support optimal gut health recovery.

Conditions

  • AML (Acute Myelogenous Leukemia
  • HLH
  • Burkitt Lymphoma/Leukemia

Interventions

DIETARY_SUPPLEMENT

Enteral nutrition Food Derived Ingredient

For this case-control analysis, children with AML will be matched to cancer-free controls for age, sex and race. No antibiotics for 6 months. In collaboration with Professor Konstantinos Gerasimidis Professor of Clinical Nutrition School of Medicine. University of Glasgow. Healthy children have been recruited from the community via poster and social media advertisement. The whole bowel movement was collected in a disposable stool collection kit and stored in a benchtop freezer provided to study participants. Researcher defrosted the sample, homogenised it with mechanical kneading and aliquots were stored in -80. Cases: children with AML: Stool specimens will be obtained at three predefined time points for microbiome analysis: baseline start of AML treatment (within 2 weeks of admission); after induction chemotherapy initiation (6-8weeks); recovery phase 6-8 months.

Sponsors & Collaborators

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
1 Month
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-30
Primary Completion
2026-07-30
Completion
2026-10-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06899581 on ClinicalTrials.gov