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NCT Number: NCT01600781

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

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.

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Key information

Conditions

Acute Lymphocytic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's cancer Hospital Egypt-57357

Cairo, 11441, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NutriniDrink/Fortini MF unflavoured (1.5kcal/ml)

Dietary Supplement

During the 6-week Intervention period children allocated to group 1 will consume 2 bottles of study product per day (400ml in total).

Primary outcomes

  1. 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 [%]

Secondary outcomes

  1. 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 [%]

Sponsors and collaborators

Lead sponsor

Children's Cancer Hospital Egypt 57357

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 17, 2012
Registry last updated
Feb 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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