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

Children's Cancer Hospital Egypt 57357

Status: Completed

Conditions: Acute Lymphocytic Leukemia

Treatments: Dietary Supplement: NutriniDrink/Fortini MF unflavoured (1.5kcal/ml)

Study type: Interventional

Funder types: Other

Identifiers

NCT01600781

CCHE-ALL001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

NutriniDrink/Fortini group

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: NutriniDrink/Fortini MF unflavoured (1.5kcal/ml)

control group

No Intervention group

Description:

this control group will only receive standard dietary counselling