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

Acute Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600781
• Other study ID #: CCHE-ALL001
• Status: Completed
• Phase: N/A
• First received: May 15, 2012
• Last updated: February 8, 2015
• Start date: December 2011
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: Children's Cancer Hospital Egypt 57357
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Dietary Supplement:
• NutriniDrink/Fortini MF unflavoured (1.5kcal/ml)
During the 6-week Intervention period children allocated to group 1 will consume 2 bottles of study product per day (400ml in total).

Locations

Country	Name	City	State
Egypt	Children's cancer Hospital Egypt-57357	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer Hospital Egypt 57357

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes