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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
40
Based on assessment by a dietician the participant will be fed the commercial blenderized formula to meet their caloric needs
Participant will be fed the commercial formula to meet their caloric needs per standard of care
The University of Texas Health Science Center at Houston
Houston, Texas, United States
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.
Time frame: Baseline, end of study (2 months after baseline)
Change in fecal samples for microbiome analysis (identity, composition, and relative abundance of bacterial taxa in stool specimens)
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: Baseline, end of study (2 months after baseline)
Number of participants who had dose adjustments to their antacid or laxative medications
Time frame: Baseline, end of study (2 months after baseline)
Change in weight
Time frame: Baseline, end of study (2 months after baseline)
Change in weight percentile
Time frame: Baseline, end of study (2 months after baseline)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.