The Impact of Commercial Blenderized Formula on Caloric Needs, Gastrointestinal Symptoms, and Gut Microbiome in Children With Cerebral Palsy (CP)
- Conditions
- Cerebral Palsy
- Interventions
- Dietary Supplement: commercial formulas (CF)Dietary Supplement: commercial blenderized tube feed (CBTF)
- Registration Number
- NCT06488560
- 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 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description commercial formulas (CF) commercial formulas (CF) - commercial blenderized tube feed (CBTF) commercial blenderized tube feed (CBTF) -
- Primary Outcome Measures
Name Time Method Change in quality of life as assessed by the Pediatric QoL Inventory of GI Symptom Scale. Baseline, end of study (2 months after baseline) This is a 74 item questionnaire and each is scored from 0 (never) to 4 (almost always), higher score indicating worse outcome.
- Secondary Outcome Measures
Name Time Method Change in weight percentile Baseline, end of study (2 months after baseline) Change in stool metabolomic profile Baseline, end of study (2 months after baseline) Mass spectrometry will be used to assess the following metabolites: amino acids, methylated metabolites, bile acids, and nucleotides.
Change in salivary cytokine profile Baseline, end of study (2 months after baseline) 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).
Number of participants who needed to add or remove antacid or laxative medications from their bowel regimen Baseline, end of study (2 months after baseline) Medications in the bowel regimen include antacids and laxatives.
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 weight 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 stool caliber using the Bristol stool scale Baseline, end of study (2 months after baseline) 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)
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States