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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NutriniDrink/Fortini group | Active Comparator | 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. |
|
| control group | No Intervention | this control group will only receive standard dietary counselling |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Study Parameters | Primary
| 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Study Parameters |
| from day 1 to day 91 of the study |
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Inclusion Criteria:• Newly diagnosed male and female paediatric ALL patients presenting in the study period.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alaa El-Hadad, PhD | Children's Cancer Hospita Egypt-57357 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's cancer Hospital Egypt-57357 | Cairo | 11441 | Egypt |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |