Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

Study Overview
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Brief Summary
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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.

Official Title
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A Novel N-of-1 Randomized, Controlled, Clinical Trial to Assess the Effect of Blenderized Tube Feeds on Esophagogastric Physiology

Conditions
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Feeding Disorders

Intervention / Treatment
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* Other: Extremely thick blenderized tube feed
* Other: Mildly thick blenderized tube feed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick<br>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. | Other: Extremely thick blenderized tube feed<br>* Commercial blenderized tube feed, not diluted<br>Other: Mildly thick blenderized tube feed<br>* Commercial blenderized tube feed, diluted with ingredients contained in blend<br>|
| Experimental: Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick<br>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. | Other: Extremely thick blenderized tube feed<br>* Commercial blenderized tube feed, not diluted<br>Other: Mildly thick blenderized tube feed<br>* Commercial blenderized tube feed, diluted with ingredients contained in blend<br>|
| Experimental: Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick<br>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. | Other: Extremely thick blenderized tube feed<br>* Commercial blenderized tube feed, not diluted<br>Other: Mildly thick blenderized tube feed<br>* Commercial blenderized tube feed, diluted with ingredients contained in blend<br>|
| Experimental: Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick<br>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. | Other: Extremely thick blenderized tube feed<br>* Commercial blenderized tube feed, not diluted<br>Other: Mildly thick blenderized tube feed<br>* Commercial blenderized tube feed, diluted with ingredients contained in blend<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptoms | Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Questionnaire, scale of 0 to 100, higher scores indicate less symptom burden | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | 
| Gastrointestinal symptoms | Pediatric Quality of Life Inventory Gastroparesis Questionnaire, , scale of 0 to 100, higher scores indicate less symptom burden | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | 
| Pulmonary symptoms | Pediatric Cough Questionnaire, score ranges from 0 to 25, higher scores indicate less symptom burden | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | 
| Health care utilization | frequency of hospital admissions | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | 
| Health care utilization | length of hospital admissions | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | 
| Health care utilization | rates of ER/urgent care visits | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | 
| GI medication use | % of participants requiring acid suppressive medication or GI motility agents such as cyproheptadine and erythromycin | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | 
| Height | height | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | 
| Weight | Weight or weight for length | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | 
| Weight for height/body mass index (BMI) | weight for height (children < 2) or BMI (over 2 years of age) | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | 
| number of patients with unplanned G-tube exchange |  | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | 
| urine output adequacy | frequency of urine output | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | 
| rate of respiratory suctioning per day | how often suctioning is required (e.g. number of times per day) | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) | 
| need for antibiotics for pneumonitis | frequency of antibiotics prescribed for pulmonary indications | 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) |