Clinical Trial of Blenderized Tube Feeds Varying in Viscosity
A Novel N-of-1 Randomized, Controlled, Clinical Trial to Assess the Effect of Blenderized Tube Feeds on Esophagogastric Physiology
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedStudy Start
First participant enrolled
October 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
April 17, 2026
April 1, 2026
4 years
June 7, 2022
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Upper GI symptoms
differences in daily parental rating of upper gastrointestinal symptoms from the validated Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) between extremely and mildly thick blenderized tube feeds
8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Secondary Outcomes (14)
Gastrointestinal symptoms
8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Gastrointestinal symptoms
8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Pulmonary symptoms
8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Health care utilization
8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Health care utilization
8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
- +9 more secondary outcomes
Study Arms (4)
Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick
EXPERIMENTALParticipants 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.
Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick
EXPERIMENTALParticipants 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.
Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick
EXPERIMENTALParticipants 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.
Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick
EXPERIMENTALParticipants 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.
Interventions
Commercial blenderized tube feed, not diluted
Commercial blenderized tube feed, diluted with ingredients contained in blend
Eligibility Criteria
You may qualify if:
- age \> 1 year
- \>90% of total calories via G-tube for \> 6 months
- G-tube diameter ≥ 14 French
- moderate severity of upper GI symptoms of nausea, bloating, postprandial fullness and early satiety defined as Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) composite score \> 2
- anticipated stable GI-related medications for the duration of the study.
You may not qualify if:
- cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, bronchiolitis obliterans, or lung transplant
- untreated malabsorptive intestinal disease (e.g. Crohn's disease, celiac disease)
- Nissen fundoplication
- use of non-standard enteral formulas (e.g. ketogenic formulas) for the management of metabolic, endocrine or neurologic rare diseases
- allergy or intolerance to any component of the study diet
- inability to tolerate bolus gastric feeds.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician
Study Record Dates
First Submitted
June 7, 2022
First Posted
June 14, 2022
Study Start
October 12, 2023
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share