Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

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

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.

Study Overview

• Status: Recruiting
• Conditions: Feeding Disorders
• Intervention / Treatment: Other: Extremely thick blenderized tube feed; Other: Mildly thick blenderized tube feed

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Bridget M Hron, MD; Phone Number: 617-355-1433; Email: bridget.hron@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick; 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; Commercial blenderized tube feed, not diluted; Other: Mildly thick blenderized tube feed; Commercial blenderized tube feed, diluted with ingredients contained in blend
Experimental: Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick; 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; Commercial blenderized tube feed, not diluted; Other: Mildly thick blenderized tube feed; Commercial blenderized tube feed, diluted with ingredients contained in blend
Experimental: Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick; 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; Commercial blenderized tube feed, not diluted; Other: Mildly thick blenderized tube feed; Commercial blenderized tube feed, diluted with ingredients contained in blend
Experimental: Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick; 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; Commercial blenderized tube feed, not diluted; Other: Mildly thick blenderized tube feed; Commercial blenderized tube feed, diluted with ingredients contained in blend

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: IRB-P00042262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No