Language: BG BG
← Back to results
Recruiting Not applicable NCT05417958

Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

No applicable phase (e.g. observational)
Conditions: Feeding Disorders

Sponsor: Boston Children's Hospital

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
Extremely thick blenderized tube feed
OTHER
Mildly thick blenderized tube feed
OTHER
Locations 1
United States (1)
Boston Children's Hospital
Boston , Massachusetts
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
1 Year
Healthy volunteers
No
Start date
12.10.2023
Completion date
01.04.2028
Registry ID
NCT05417958
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.