Clinical trial NCT05417958: Clinical Trial of Blenderized Tube Feeds Varying in Viscosity
Official title: A Novel N-of-1 Randomized, Controlled, Clinical Trial to Assess the Effect of Blenderized Tube Feeds on Esophagogastric Physiology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Feeding Disorders
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Upper GI symptoms
timeFrame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Secondary outcomes:
measure: Gastrointestinal symptoms
timeFrame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
measure: Gastrointestinal symptoms
timeFrame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
measure: Pulmonary symptoms
timeFrame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
measure: Health care utilization
timeFrame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
measure: Health care utilization
timeFrame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
measure: Health care utilization
timeFrame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
measure: GI medication use
timeFrame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
measure: Height
timeFrame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
measure: Weight
timeFrame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
measure: Weight for height/body mass index (BMI)
timeFrame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
measure: number of patients with unplanned G-tube exchange
timeFrame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
measure: urine output adequacy
timeFrame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
measure: rate of respiratory suctioning per day
timeFrame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
measure: need for antibiotics for pneumonitis
timeFrame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References: