Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

Boston Children's Hospital

Status: Enrolling

Conditions: Feeding Disorders

Treatments: Other: Extremely thick blenderized tube feed; Other: Mildly thick blenderized tube feed

Study type: Interventional

Funder types: Other

Identifiers

NCT05417958

IRB-P00042262

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick

Experimental group

Description:

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.

Treatment:

Other: Mildly thick blenderized tube feed

Other: Extremely thick blenderized tube feed

Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick

Experimental group

Description:

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.

Treatment:

Other: Mildly thick blenderized tube feed

Other: Extremely thick blenderized tube feed

Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick

Experimental group

Description:

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.

Treatment:

Other: Mildly thick blenderized tube feed

Other: Extremely thick blenderized tube feed

Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick

Experimental group

Description:

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.

Treatment:

Other: Mildly thick blenderized tube feed

Other: Extremely thick blenderized tube feed