Clinical trial NCT06488560: The Impact of Commercial Blenderized Formula on Caloric Needs, Gastrointestinal Symptoms, and Gut Microbiome in Children With Cerebral Palsy (CP)
Official title: The Impact of Commercial Blenderized Formula on Caloric Needs, Gastrointestinal Symptoms, and Gut Microbiome in Children With Cerebral Palsy: A Single Center Randomized Open Label Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: Blenderized tube feeds (BTF)
commercial blenderized tube feed (CBTF)
Commercial formula
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in quality of life as assessed by the Pediatric QoL Inventory of GI Symptom Scale.
timeFrame: Baseline, end of study (2 months after baseline)
Secondary outcomes:
measure: Change in fecal samples for microbiome analysis (identity, composition, and relative abundance of bacterial taxa in stool specimens)
timeFrame: Baseline, end of study (2 months after baseline)
measure: Change in stool metabolomic profile
timeFrame: Baseline, end of study (2 months after baseline)
measure: Change in salivary cytokine profile
timeFrame: Baseline, end of study (2 months after baseline)
measure: Change in stool caliber using the Bristol stool scale
timeFrame: Baseline, end of study (2 months after baseline)
measure: Number of participants who needed to add or remove antacid or laxative medications from their bowel regimen
timeFrame: Baseline, end of study (2 months after baseline)
measure: Number of participants who had dose adjustments to their antacid or laxative medications
timeFrame: Baseline, end of study (2 months after baseline)
measure: Change in weight
timeFrame: Baseline, end of study (2 months after baseline)
measure: Change in weight percentile
timeFrame: Baseline, end of study (2 months after baseline)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Fernando Navarro
role: PRINCIPAL_INVESTIGATOR
References: