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

NCT01600781 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-02-10

No results posted yet for this study

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.

Conditions

  • Acute Lymphocytic Leukemia

Interventions

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).

Sponsors & Collaborators

  • Children's Cancer Hospital Egypt 57357

    lead OTHER

Principal Investigators

  • Alaa El-Hadad, PhD · Children's Cancer Hospita Egypt-57357

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-08-31
Completion
2014-09-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01600781 on ClinicalTrials.gov