Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

Feeding Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05417958
• Other study ID #: IRB-P00042262
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: February 2024
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• Feeding and Eating Disorders
• Feeding Disorders

Intervention

Other:
• Extremely thick blenderized tube feed
Commercial blenderized tube feed, not diluted
• Mildly thick blenderized tube feed
Commercial blenderized tube feed, diluted with ingredients contained in blend

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Health care utilization	frequency of hospital admissions	8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Secondary	Health care utilization	length of hospital admissions	8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Secondary	Health care utilization	rates of ER/urgent care visits	8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Secondary	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)
Secondary	Height	height	8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Secondary	Weight	Weight or weight for length	8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Secondary	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)
Secondary	number of patients with unplanned G-tube exchange		8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Secondary	urine output adequacy	frequency of urine output	8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Secondary	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)
Secondary	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)