Effect of Oral Supplementation With a Fibre Enriched Paediatric Sip Feed on the Nutritional Status, Gut Microbiota and Quality of Life of Children With Acute Lymphocytic Leukemia: an Egyptian Pilot Study
Study objectives:
Primary objective:
To evaluate the effect of oral supplementation with a fibre supplemented paediatric sip feed
on the nutritional status of Egyptian children with acute lymphocytic leukemia (ALL)
compared to standard dietary counseling.
Secondary objective:
To evaluate the effect of oral supplementation with a fibre supplemented paediatric sip feed
on the gut microbiota and quality of life (QoL) of Egyptian children with ALL compared to
standard dietary counseling.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Study Parameters
Primary Change in body weight between Baseline and Day 42 [kg, weight-for-age z score, weight-for-height z-score] Percentage of children with body weight loss between Baseline and Day 42 [%]
42 days
Yes
Alaa El-Hadad, PhD
Principal Investigator
Children's Cancer Hospita Egypt-57357
Egypt: Institutional Review Board
CCHE-ALL001
NCT01600781
December 2011
March 2013
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