Clinical Trial of Blenderized Tube Feeds Varying in Viscosity
Not Applicable
Recruiting
- Conditions
- Feeding Disorders
- Interventions
- Other: Extremely thick blenderized tube feedOther: Mildly thick blenderized tube feed
- Registration Number
- NCT05417958
- Lead Sponsor
- Boston Children's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick Mildly thick blenderized tube feed 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. Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick Extremely thick blenderized tube feed 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. Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick Extremely thick blenderized tube feed 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. Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick Mildly thick blenderized tube feed 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. Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick Mildly thick blenderized tube feed 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. Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick Mildly thick blenderized tube feed 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. Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick Extremely thick blenderized tube feed 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. Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick Extremely thick blenderized tube feed 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.
- Primary Outcome Measures
Name Time Method Upper GI symptoms 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) 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
- Secondary Outcome Measures
Name Time Method GI medication use 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) % of participants requiring acid suppressive medication or GI motility agents such as cyproheptadine and erythromycin
urine output adequacy 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) frequency of urine output
Gastrointestinal symptoms 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) Pediatric Quality of Life Inventory Gastroparesis Questionnaire, , scale of 0 to 100, higher scores indicate less symptom burden
Weight for height/body mass index (BMI) 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) weight for height (children \< 2) or BMI (over 2 years of age)
Health care utilization 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) rates of ER/urgent care visits
Pulmonary symptoms 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) Pediatric Cough Questionnaire, score ranges from 0 to 25, higher scores indicate less symptom burden
Height 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) height
Weight 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) Weight or weight for length
rate of respiratory suctioning per day 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) how often suctioning is required (e.g. number of times per day)
need for antibiotics for pneumonitis 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) frequency of antibiotics prescribed for pulmonary indications
number of patients with unplanned G-tube exchange 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Trial Locations
- Locations (1)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States