Blenderized Formula for Cerebral Palsy

Overseen By Ana F Alvarez

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Transpyloric feeds, Jejunal tube, Monomeric formulas, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare the Pediatric Quality of Life Inventory Gastrointestinal Symptoms Scale Gastrointestinal Symptoms Scale (GI-PedsQL) differences , to assess the differences in stool microbiome and stool metabolomics , to assess differences in salivary cytokine profile , to assess differences in weight change , to compare the use of antacid medications and to compare the use of laxative medications in patients on commercial formulas (CF) versus commercial blenderized tube feed (CBTF).

Research Team

Fernando Navarro

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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.

Inclusion Criteria

I get most of my daily calories through a feeding tube.

My insurance covers a CBTF.

I have been diagnosed with cerebral palsy.

Exclusion Criteria

Receiving <75% of total daily energy requirements from a commercial formula

My weight is either below the 5th percentile or above the 85th percentile for my age.

I have been diagnosed with a fast-progressing brain condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either commercial blenderized tube feed (CBTF) or commercial formulas (CF) to assess various health outcomes

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Commercial Blenderized Formula

Trial Overview 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.

Participant Groups

Group I: commercial blenderized tube feed (CBTF) Experimental Treatment 1 Intervention

Group II: commercial formulas (CF) Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+