NCT06488560

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

The Impact of Commercial Blenderized Formula on Caloric Needs, Gastrointestinal Symptoms, and Gut Microbiome in Children With Cerebral Palsy: A Single Center Randomized Open Label Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	commercial blenderized tube feed (CBTF)	Based on assessment by a dietician the participant will be fed the commercial blenderized formula to meet their caloric needs
DIETARY_SUPPLEMENT	commercial formulas (CF)	Participant will be fed the commercial formula to meet their caloric needs per standard of care

Timeline

• Start date: 2024-08-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-07-05
• Last updated: 2024-07-05

Locations

1 site across 1 country: United States