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Commercial Blenderized Formula for Children with Cerebral Palsy

This study is looking at how different types of tube feeding affect children with cerebral palsy (CP). It compares a commercial blenderized tube feed (CBTF) with standard commercial formulas (CF). Researchers want to see if CBTF can improve your child's quality of life, especially regarding stomach and gut symptoms. They will also look at changes in weight, gut bacteria (microbiome), and the use of antacid or laxative medications. Your child may be able to join if they are 3 to 18 years old, have CP, and get most of their nutrition through a gastrostomy tube using commercial formulas. The study aims to enroll 40 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 40 participants. It compares two different dietary interventions: commercial blenderized tube feed (CBTF) and commercial formulas (CF).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at baseline and at the end of the study, which is 2 months after baseline.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06488560

The Impact of Commercial Blenderized Formula on Caloric Needs, Gastrointestinal Symptoms, and Gut Microbiome in Children With Cerebral Palsy (CP)

UNKNOWN
NAAges 3–18InterventionalSupportive care
The University of Texas Health Science Center, Houston
~40 participants
Updated 2024-07-05 on ClinicalTrials.gov
What's tested:commercial blenderized tube feed (CBTF)commercial formulas (CF)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in quality of life as assessed by the Pediatric QoL Inventory of GI Symptom Scale.
Measured over Baseline, end of study (2 months after baseline)

Conditions

Cerebral Palsy

Explore related trials

Cerebral Palsy

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Fernando Navarro · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Fernando Navarro, MD
[email protected]
(713) 500-5663
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients with CP receiving \>75% of total daily caloric requirements from commercial formulas (CF) via a gastrostomy tube 12french or greater
Patients' insurance covers a CBTF
Diagnosis of cerebral palsy

Exclusion

Receiving enteral nutrition by transpyloric feeds or jejunal tube.
Receiving \<75% of total daily energy requirements from a commercial formula
Weight or weight for length or body mass index less than the 5th percentile for age or greater than the 85th% percentile for age when plotted on the cerebral palsy growth chart
Rapidly progressive neurodegenerative disease diagnosis
Use of monomeric formulas

What this trial measures

  • Change in quality of life as assessed by the Pediatric QoL Inventory of GI Symptom Scale.Baseline, end of study (2 months after baseline)

    This is a 74 item questionnaire and each is scored from 0 (never) to 4 (almost always), higher score indicating worse outcome.