Clinical trial NCT01600781: Effect of Oral Supplementation With a Fibre Enriched Paediatric Sip Feed For Children With Acute Lymphocytic Leukemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lymphocytic Leukemia
Keywords: Improve the nutritional status
QOL
children
enhance immune response
induction chemotherapy
fewer side effects
Lead sponsor: Children's Cancer Hospital Egypt 57357
Sponsor class: OTHER
First posted: 2012-05-17
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:• Newly diagnosed male and female paediatric ALL patients presenting in the study period.

* Age should be above 2 years and children should be pre-pubertal.
* 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 \< 2 years and those who show signs of puberty.
* 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.

Primary outcomes:
measure: Study Parameters
timeFrame: 42 days
Secondary outcomes:
measure: Study Parameters
timeFrame: from day 1 to day 91 of the study
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Children's cancer Hospital Egypt-57357
Study officials:
affiliation: Children's Cancer Hospita Egypt-57357
name: Alaa El-Hadad, PhD
role: PRINCIPAL_INVESTIGATOR
References: