Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

The University of Texas Health Science Center, Houston

Conditions:

Cerebral Palsy

Eligibility:

All Genders

3-18 years

Phase:

NA

Brief Summary

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 s...

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

Key Trial Info

Start Date :

August 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2024

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT06488560

Start Date

August 1 2024

End Date

December 31 2024

Last Update

July 5 2024

Active Locations (1)

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The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030