Gut Health in Children With Cancer

NCT06899581 | Recruiting DMC

• 1 other identifier: IRAS345223:23SH27
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Gut microbiome

  (1a) differences in the alpha and beta-diversity throughout AML treatment and recovery phases 1. b) differences in the alpha and beta diversity at baseline between case and controls 2. a) differences in the Firmicutes to Bacteroidetes ratio throughout AML treatment and recovery phases (2b) differences in the Firmicutes to Bacteroidetes ratio baseline between case and controls (3a) differences in gut microbiome composition throughout AML treatment and recovery phases (3b) differences in gut microbiome composition baseline between case and controls

  6 months

Secondary Outcomes (1)

• Anthropometry

  6 months

Interventions

Enteral nutrition Food Derived Ingredient DIETARY_SUPPLEMENT

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.

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children

You may qualify if:

• \- Consented to partake in the study
• Aged 0-16 years old
• Diagnosed with AML/HLH/ Burkits

You may not qualify if:

• years old + (treated at UCL adolescent unit)
• Inflammatory bowel disease: ulcerative colitis or Crohn's disease
• Children who had previously been treated with chemotherapy in another institution age

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead

Study Sites (1)

Great Ormond Street Hospital

London, WC1N 3JH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Graeme O'Connor, PhD

CONTACT

+4474059200; graeme.oconnor@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start: January 30, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Nov 2026

Locations

GB (1)