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Dietary Supplement
Blenderized Formula for Cerebral Palsy
N/A
Waitlist Available
Led By Fernando Navarro
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients' insurance covers a CBTF
Patients with CP receiving >75% of total daily caloric requirements from commercial formulas (CF) via a gastrostomy tube 12french or greater
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, end of study (2 months after baseline)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to compare the quality of life, stool microbiome, stool metabolites, salivary cytokines, weight change, and medication use in patients using commercial formulas versus those using commercial blender
Who is the study for?
This trial is for children with Cerebral Palsy who need nutritional support through tube feeding. It's comparing two types of tube feedings: standard commercial formulas and blenderized foods made commercially. Kids must be stable enough to participate, without recent changes in their feeding regimen.
What is being tested?
The study aims to see if there are differences in gastrointestinal health, gut bacteria, body inflammation markers, weight change, and the need for medications to manage stomach acid or bowel movements between kids on commercial formula versus those on blenderized feeds.
What are the potential side effects?
Potential side effects may include changes in digestive comfort like gas or bloating, alterations in bowel habits such as constipation or diarrhea, and possible reactions related to the gut microbiome shift due to different diets.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My insurance covers a CBTF.
Select...
I get most of my daily calories through a feeding tube.
Select...
I have been diagnosed with cerebral palsy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My weight is either below the 5th percentile or above the 85th percentile for my age.
Select...
I have been diagnosed with a fast-progressing brain condition.
Select...
I am receiving nutrition through a tube into my intestine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, end of study (2 months after baseline)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, end of study (2 months after baseline)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in quality of life as assessed by the Pediatric QoL Inventory of GI Symptom Scale.
Secondary study objectives
Change in salivary cytokine profile
Change in stool caliber using the Bristol stool scale
Change in stool metabolomic profile
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: commercial blenderized tube feed (CBTF)Experimental Treatment1 Intervention
Group II: commercial formulas (CF)Active Control1 Intervention
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
949 Previous Clinical Trials
344,985 Total Patients Enrolled
2 Trials studying Cerebral Palsy
35 Patients Enrolled for Cerebral Palsy
Fernando NavarroPrincipal InvestigatorThe University of Texas Health Science Center, Houston
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