An interventional study of NutriniDrink/Fortini MF unflavoured (1.5kcal/ml) in Acute Lymphocytic Leukemia, sponsored by Children's Cancer Hospital Egypt 57357. Completed at 1 site in Egypt. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2015-02-10.
Sponsored by Children's Cancer Hospital Egypt 57357 · Not applicable, Interventional, and Supportive care
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 120 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Children's Cancer Hospital Egypt 57357 is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
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Inclusion Criteria:• Newly diagnosed male and female paediatric ALL patients presenting in the study period.
Exclusion Criteria:
this group will receive 2 bottles of NutriniDrink/Fortini MF unflavoured daily (200 ml each) and standard dietary counselling for a period of 6 weeks.
Dietary Supplement: NutriniDrink/Fortini MF unflavoured (1.5kcal/ml)
this control group will only receive standard dietary counselling
During the 6-week Intervention period children allocated to group 1 will consume 2 bottles of study product per day (400ml in total).
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
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Children's Cancer Hospital Egypt 57357