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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Lymphocytic Leukemia

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NutriniDrink/Fortini group<br>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)<br>* During the 6-week Intervention period children allocated to group 1 will consume 2 bottles of study product per day (400ml in total).<br>|
| No Intervention: control group<br>this control group will only receive standard dietary counselling | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Parameters | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Improve the nutritional status, QOL, children, enhance immune response, induction chemotherapy, fewer side effects