Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT05417958
Status
Recruiting
Apply to this trial

Conditions

  • Feeding Disorders

Eligibility Criteria

Sex
ALL
Age
1 Year - N/A
Healthy Volunteers
Not accepted

Interventions

  • Extremely thick blenderized tube feed — OTHER
    Commercial blenderized tube feed, not diluted
  • Mildly thick blenderized tube feed — OTHER
    Commercial blenderized tube feed, diluted with ingredients contained in blend

Study Details

The investigators are conducting a 16 week multiple cross-over study (N-of-1 trial) comparing two blenderized tube feeds varying in viscosity in 40 children.

Key Dates

Start date
Oct 12, 2023
Status verified
Apr 2026
Primary completion
Oct 1, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick
    Participants will receive 4 weeks Extremely Thick, 4 weeks Mildly Thick, 4 weeks Extremely Thick and 4 weeks Mildly Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.
  • Experimental: Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick
    Participants will receive 4 weeks Extremely Thick, 4 weeks Mildly Thick, 4 weeks Mildly Thick and 4 weeks Extremely Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.
  • Experimental: Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick
    Participants will receive 4 weeks Mildly Thick, 4 weeks Extremely Thick, 4 weeks Extremely Thick and 4 weeks Mildly Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.
  • Experimental: Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick
    Participants will receive 4 weeks Mildly Thick, 4 weeks Extremely Thick, 4 weeks Mildly Thick and 4 weeks Extremely Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.

Primary Outcome Measure

Upper GI symptoms [ Time Frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Bridget M Hron, MD
[email protected]
6173551433

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By research site
Boston Children's Hospital· Boston, MA

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