Acute Lymphocytic LeukemiaNCT01600781
Effect of Oral Supplementation With a Fibre Enriched Paediatric Sip Feed For Children With Acute Lymphocytic Leukemia
A study testing NutriniDrink/Fortini MF unflavoured (1.5kcal/ml) in people with Acute Lymphocytic Leukemia, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Acute Lymphocytic Leukemia
- What is being tested?
- NutriniDrink/Fortini MF unflavoured (1.5kcal/ml)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2011to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Acute Lymphocytic Leukemia
- Being tested
- NutriniDrink/Fortini MF unflavoured (1.5kcal/ml)
- Keywords
- Improve the nutritional status, QOL, children, enhance immune response, induction chemotherapy, fewer side effects
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: NutriniDrink/Fortini MF unflavoured (1.5kcal/ml) |
| control group | No intervention | this control group will only receive standard dietary counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 [%]
Measured: 42 days
Secondary outcomes (1)
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 [%]
Measured: from day 1 to day 91 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startDec 2011
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Cancer Hospital Egypt 57357
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alaa El-Hadad, PhD, Principal investigator, Children's Cancer Hospita Egypt-57357
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600781
- Sponsor's protocol ID
- CCHE-ALL001
- Status last verified
- Feb 2015
- First submitted
- 15 May 2012
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01600781
- Acronym / sponsor ID
- CCHE-ALL001
- Conditions
- Acute Lymphocytic Leukemia
- Keywords
- Improve the nutritional status, QOL, children, enhance immune response, induction chemotherapy, fewer side effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Children's Cancer Hospital Egypt 57357University, hospital or other
- Study start
- Dec 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NutriniDrink/Fortini group | Active comparator | Dietary Supplement: NutriniDrink/Fortini MF unflavoured (1.5kcal/ml)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 |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Dietary supplement | NutriniDrink/Fortini group |
Primary outcome
Study Parameters
Time frame: 42 days
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 [%]
1 secondary outcome
Study Parameters
Time frame: from day 1 to day 91 of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa El-Hadad, PhD principal investigator
Children's Cancer Hospita Egypt-57357
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NutriniDrink/Fortini MF unflavoured (1.5kcal/ml) in people with Acute Lymphocytic Leukemia, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Parameters (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.