Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

Sponsor

Boston Children's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05417958

Collaborator

(none)

Enrollment

Arms

58.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Feeding Disorders	Other: Extremely thick blenderized tube feed Other: Mildly thick blenderized tube feed	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2027

Anticipated Study Completion Date :

Jun 30, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Gastrointestinal symptoms [8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)]
Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Questionnaire, scale of 0 to 100, higher scores indicate less symptom burden
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
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
Health care utilization [8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)]
frequency of hospital admissions
Health care utilization [8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)]
length of hospital admissions
Health care utilization [8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)]
rates of ER/urgent care visits
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
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
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)
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 [8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)]
frequency of urine output
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Boston Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bridget Hron, Staff Physician, Boston Children's Hospital

ClinicalTrials.gov Identifier:

NCT05417958

Other Study ID Numbers:

IRB-P00042262

First Posted:

Jun 14, 2022

Last Update Posted:

Jul 19, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Feeding and Eating Disorders

Study Results

No Results Posted as of Jul 19, 2022