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

Not Applicable

Completed

• Conditions: Acute Lymphocytic Leukemia
• Interventions: Dietary Supplement: NutriniDrink/Fortini MF unflavoured (1.5kcal/ml)

• Registration Number: NCT01600781
• Lead Sponsor: Children's Cancer Hospital Egypt 57357

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-05-15
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-17
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-08
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NutriniDrink/Fortini group	NutriniDrink/Fortini MF unflavoured (1.5kcal/ml)	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.

Primary Outcome Measures

Name	Time	Method
Study Parameters	42 days	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 \[%\]

Secondary Outcome Measures

Name	Time	Method
Study Parameters	from day 1 to day 91 of the study	* 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 \[%\]

Trial Locations

Locations (1)

Children's cancer Hospital Egypt-57357; 🇪🇬 Cairo, Egypt