Cerebral Palsy
Conditions
Keywords
Blenderized tube feeds (BTF), commercial blenderized tube feed (CBTF), Commercial formula
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).
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
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
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 progressive neurodegenerative disease diagnosis * Use of monomeric formulas
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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) |
| 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) | — |
| 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) | — |
| 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. |
Countries
United States
Contacts
Primary ContactFernando Navarro, MD
Backup ContactAna F Alvarez
Outcome results
None listed