Clinical Trial of Blenderized Tube Feeds Varying in Viscosity
ConditionFeeding Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1+
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Extremely thick blenderized tube feed
Other interventionCommercial blenderized tube feed, not diluted
Mildly thick blenderized tube feed
Other interventionCommercial blenderized tube feed, diluted with ingredients contained in blend
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: Extremely Thick - Mildly Thick - Extremely Thick - Mildly ThickExperimental treatment 2 interventions
Group B: Extremely Thick - Mildly Thick - Mildly Thick - Extremely ThickExperimental treatment 2 interventions
Group C: Mildly Thick - Extremely Thick - Extremely Thick - Mildly ThickExperimental treatment 2 interventions
Group D: Mildly Thick - Extremely Thick - Mildly Thick - Extremely ThickExperimental treatment 2 interventions
Trial outcomes
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
Time frame
8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)Secondary outcomes
1
Gastrointestinal symptoms
Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Questionnaire, scale of 0 to 100, higher scores indicate less symptom burden
Time frame
8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)2
Gastrointestinal symptoms
Pediatric Quality of Life Inventory Gastroparesis Questionnaire, , scale of 0 to 100, higher scores indicate less symptom burden
Time frame
8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)3
Pulmonary symptoms
Pediatric Cough Questionnaire, score ranges from 0 to 25, higher scores indicate less symptom burden
Time frame
8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)4
Health care utilization
frequency of hospital admissions
Time frame
8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)Sponsors and contacts
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Source ClinicalTrials.gov