The Impact of Commercial Blenderized Formula on Caloric Needs, Gastrointestinal Symptoms, and Gut Microbiome in Children With Cerebral Palsy (CP)
NCT Number: NCT06488560
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy
Interventions: DIETARY_SUPPLEMENT: commercial blenderized tube feed (CBTF)|DIETARY_SUPPLEMENT: commercial formulas (CF)
Sponsor: The University of Texas Health Science Center, Houston
Sex: ALL
Age: CHILD, ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-01
Completion Date: 2024-12-31
Locations: The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States

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).

Primary Outcome Measures: Change in quality of life as assessed by the Pediatric QoL Inventory of GI Symptom Scale., This is a 74 item questionnaire and each is scored from 0 (never) to 4 (almost always), higher score indicating worse outcome., Baseline, end of study (2 months after baseline)
Secondary Outcome Measures: Change in fecal samples for microbiome analysis (identity, composition, and relative abundance of bacterial taxa in stool specimens), Baseline, end of study (2 months after baseline)|Change in stool metabolomic profile, Mass spectrometry will be used to assess the following metabolites: amino acids, methylated metabolites, bile acids, and nucleotides., Baseline, end of study (2 months after baseline)|Change in salivary cytokine profile, Gene expression of the following salivary inflammatory cytokines will be assessed: interleukin-8 (IL-8), toll-like receptor 8 (TLR8), interleukin-26 (IL-26), interleukin-22 (IL-22), C-C motif chemokine receptor type 1 (CCR1), Caspase 2 (CASP2), toll-like receptor 8 (TLR8), and Intercellular adhesion molecule 3 (ICAM3)., Baseline, end of study (2 months after baseline)|Change in stool caliber using the Bristol stool scale, The Bristol stool scale categorizes stool into one of 7 types, as follows. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, and 6 and 7 indicate diarrhea.

Type 1: Separate hard lumps, like nuts (difficult to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft (average stool) Type 5: Soft blobs with clear cut edges Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea) Type 7: Watery, no solid pieces, entirely liquid (diarrhea), Baseline, end of study (2 months after baseline)|Number of participants who needed to add or remove antacid or laxative medications from their bowel regimen, Medications in the bowel regimen include antacids and laxatives., Baseline, end of study (2 months after baseline)|Number of participants who had dose adjustments to their antacid or laxative medications, Baseline, end of study (2 months after baseline)|Change in weight, Baseline, end of study (2 months after baseline)|Change in weight percentile, Baseline, end of study (2 months after baseline)