Effect of Oral Supplementation With a Fibre Enriched Paediatric Sip Feed For Children With Acute Lymphocytic Leukemia
NCT ID: NCT01600781
Last Updated: 2015-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2011-12-31
2014-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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NutriniDrink/Fortini group
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.
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).
control group
this control group will only receive standard dietary counselling
No interventions assigned to this group
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Hospitalized for the entire (6 week) intervention period.
* About to receive? induction chemotherapy.
* Able to tolerate oral feeding.
* Written informed consent from parents/guardian (and child, if applicable to local law).
Exclusion Criteria
* ALL patients who cannot tolerate oral feeding and/or are on parenteral nutrition.
* ALL patients with a known history of cow's milk allergy/intolerance or galactosemia.
* ALL patients requiring a fibre-free diet.
* Investigator's uncertainty about the willingness or ability of the child/carer to comply with the protocol requirements.
* Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
2 Years
12 Years
ALL
No
Sponsors
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Children's Cancer Hospital Egypt 57357
OTHER
Responsible Party
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Principal Investigators
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Alaa El-Hadad, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Cancer Hospita Egypt-57357
Locations
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Children's cancer Hospital Egypt-57357
Cairo, , Egypt
Countries
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Other Identifiers
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CCHE-ALL001
Identifier Type: -
Identifier Source: org_study_id
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