Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NutriniDrink/Fortini MF unflavoured (1.5kcal/ml) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- NutriniDrink/Fortini 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.
- interventionNames
- Dietary Supplement: NutriniDrink/Fortini MF unflavoured (1.5kcal/ml)
- type
- NO_INTERVENTION
- label
- control group
- description
- this control group will only receive standard dietary counselling
Primary outcomes (1)
- measure
- Study Parameters
- timeFrame
- 42 days
- description
- 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 \[%\]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 12 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available