The Impact of Commercial Blenderized Formula on Caloric Needs, Gastrointestinal Symptoms, and Gut Microbiome in Children With Cerebral Palsy (CP)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Dietary supplement: commercial blenderized tube feed (CBTF); Dietary supplement: commercial formulas (CF)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fernando Navarro, MD; Phone Number: (713) 500-5663; Email: Fernando.Navarro@uth.tmc.edu
• Study Contact Backup: Name: Ana F Alvarez; Phone Number: (713) 500-5663; Email: Ana.B.FadhelAlvarez@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Ana F Alvarez; Phone Number: (713) 500-5663; Email: Ana.B.FadhelAlvarez@uth.tmc.edu
      • Contact: Fernando Navarro, MD; Phone Number: 713-500-5663; Email: Fernando.Navarro@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: commercial blenderized tube feed (CBTF)	Dietary supplement: commercial blenderized tube feed (CBTF); Based on assessment by a dietician the participant will be fed the commercial blenderized formula to meet their caloric needs
Active Comparator: commercial formulas (CF)	Dietary supplement: commercial formulas (CF); Participant will be fed the commercial formula to meet their caloric needs per standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Fernando Navarro, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Blenderized tube feeds (BTF); commercial blenderized tube feed (CBTF); Commercial formula
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: HSC-MS-24-0047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No