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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06488560
Status
Not Yet Recruiting

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Conditions

  • Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
3 Years - 18 Years
Healthy Volunteers
Not accepted

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 formulas (CF) — DIETARY_SUPPLEMENT
    Participant will be fed the commercial formula to meet their caloric needs per standard of care

Study Details

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).

Key Dates

Start date
Aug 1, 2024
Status verified
Jun 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: commercial blenderized tube feed (CBTF)
  • Active Comparator: commercial formulas (CF)

Primary Outcome Measure

Change in quality of life as assessed by the Pediatric QoL Inventory of GI Symptom Scale. [ Time Frame: Baseline, end of study (2 months after baseline) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Fernando Navarro, MD
[email protected]
713-500-5663
Ana F Alvarez
[email protected]
(713) 500-5663

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By research site
The University of Texas Health Science Center at Houston· Houston, TX

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