Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Behaviors and Mental Disorders

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Quality of Life

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

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.

this control group will only receive standard dietary counselling

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

NutriniDrink/Fortini MF unflavoured (1.5kcal/ml)

Alaa El-Hadad, PhD

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 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.

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

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

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 \[%\]

* 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 \[%\]

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effect of Oral Supplementation With a Fibre Enriched Paediatric Sip Feed For Children With Acute Lymphocytic Leukemia	NCT01600781	Acute Lymphocyt...	NutriniDrink/Fo...	2 Years - 12 Years	Children's Cancer Hospital Egypt 57357
Effect of Oral Supplementation With a Fibre Enriched Paediatric Sip Feed For Children With Acute Lymphocytic Leukemia	NCT01600781	Acute Lymphocyt...	NutriniDrink/Fo...	2 Years - 12 Years	Children's Cancer Hospital Egypt 57357

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