Gut Health in Children With Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-16
SponsorGreat Ormond Street Hospital for Children NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- Consented to partake in the study
Aged 0-16 years old
Diagnosed with AML/HLH/ Burkits
Disqualifiers
17 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
Trial population
children
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Enteral nutrition Food Derived Ingredient
Dietary supplementFor 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.
Treatment groups
No treatment groups listed
Trial outcomes
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
Time frame
6 monthsSecondary outcomes
1
Anthropometry
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov