Recruiting

Blenderized Tube Feeds

Sponsor:

Boston Children's Hospital

Code:

NCT05417958

Conditions

Feeding Disorders

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Interventions

Extremely thick blenderized tube feed

Mildly thick blenderized tube feed

Study Details

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.

Conditions

Feeding Disorders

Study ID

NCT05417958

Start date

Oct 12, 2023

Status verified date

Apr, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

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

Primary outcome measure

  • Upper GI symptoms [ Time Frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) ]

Central Contacts and Locations

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Bridget M Hron, MD

6173551433bridget.hron@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-04-17.