This is a randomised, controlled, open-label intervention study. It is hypothesized that supplementation with a fibre enriched sip feed will improve the nutritional status, gut microbiota and quality of life (QOL) of children with acute lymphoblastic leukemia, and may enhance their immune response. This could give them a better chance to finish their induction chemotherapy successfully with fewer side effects.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
120
During the 6-week Intervention period children allocated to group 1 will consume 2 bottles of study product per day (400ml in total).
Children's cancer Hospital Egypt-57357
Cairo, Egypt
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 \[%\]
Time frame: 42 days
Study Parameters
* Stool microbiota at Baseline and at Day 42 \[proportion of Bifidobacteria, total stool culture\] * Quality of life at Baseline, at Day 42 and Day 91 \[PedsQL Cancer Module\] * Change in body weight between Baseline and Day 91 \[kg, weight-for-age z score, weight-for-height z-score\] * Percentage of children with body weight loss between Baseline and Day 91 \[%\]
Time frame: from day 1 to day 91 of the study
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