NCT01600781

Effect of Oral Supplementation With a Fibre Enriched Paediatric Sip Feed For Children With Acute Lymphocytic Leukemia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Children's Cancer Hospital Egypt 57357 · Academic / Other
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Lymphocytic Leukemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	NutriniDrink/Fortini MF unflavoured (1.5kcal/ml)	During the 6-week Intervention period children allocated to group 1 will consume 2 bottles of study product per day (400ml in total).

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2012-05-17
• Last updated: 2015-02-10

Locations

1 site across 1 country: Egypt