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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| commercial blenderized tube feed (CBTF) | Experimental |
| |
| commercial formulas (CF) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| commercial blenderized tube feed (CBTF) | Dietary Supplement | Based on assessment by a dietician the participant will be fed the commercial blenderized formula to meet their caloric needs |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fernando Navarro, MD | Contact | (713) 500-5663 | Fernando.Navarro@uth.tmc.edu | |
| Ana F Alvarez | Contact | (713) 500-5663 | Ana.B.FadhelAlvarez@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Fernando Navarro | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| commercial formulas (CF) | Dietary Supplement | Participant will be fed the commercial formula to meet their caloric needs per standard of care |
|
| 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) |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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