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
The University of Texas Health Science Center, Houston
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).
Eligibility
- Age range
- 3–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * 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 progressiv…
Interventions
- Dietary Supplementcommercial 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 Supplementcommercial formulas (CF)
Participant will be fed the commercial formula to meet their caloric needs per standard of care
Location
- The University of Texas Health Science Center at HoustonHouston, Texas