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

February 8, 2015 updated by: Children's Cancer Hospital Egypt 57357

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11441
        • Children's cancer Hospital Egypt-57357

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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).
No Intervention: control group
this control group will only receive standard dietary counselling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study Parameters
Time Frame: 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 [%]
42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study Parameters
Time Frame: 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 [%]
from day 1 to day 91 of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Cancer Hospital Egypt 57357

Investigators

  • Principal Investigator: Alaa El-Hadad, PhD, Children's Cancer Hospita Egypt-57357

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 15, 2012

First Submitted That Met QC Criteria

May 16, 2012

First Posted (Estimate)

May 17, 2012

Study Record Updates

Last Update Posted (Estimate)

February 10, 2015

Last Update Submitted That Met QC Criteria

February 8, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCHE-ALL001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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