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

NCT06488560 | Not Yet Recruiting DMC

• 1 other identifier: HSC-MS-24-0047
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Cerebral Palsy

Keywords

Blenderized tube feeds (BTF); commercial blenderized tube feed (CBTF); Commercial formula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  Baseline, end of study (2 months after baseline)

• Change in salivary cytokine profile

  Baseline, end of study (2 months after baseline)

• Change in stool caliber using the Bristol stool scale

  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)

Study Arms (2)

commercial blenderized tube feed (CBTF)

EXPERIMENTAL

Dietary Supplement: commercial blenderized tube feed (CBTF)

commercial formulas (CF)

ACTIVE COMPARATOR

Dietary Supplement: commercial formulas (CF)

Interventions

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

commercial blenderized tube feed (CBTF)

commercial formulas (CF) DIETARY_SUPPLEMENT

Participant will be fed the commercial formula to meet their caloric needs per standard of care

commercial formulas (CF)

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Fernando Navarro

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: July 5, 2024
• Study Start: August 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)