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NCT Number: NCT05417958

Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

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.

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Key information

Conditions

Feeding Disorders Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Bridget M Hron, MD

CONTACT

[email protected]

6173551433

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extremely thick blenderized tube feed

Other

Commercial blenderized tube feed, not diluted

Mildly thick blenderized tube feed

Other

Commercial blenderized tube feed, diluted with ingredients contained in blend

Primary outcomes

  1. Upper GI symptoms

    Time frame: 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 outcomes

  1. Gastrointestinal symptoms

    Time frame: 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

  2. Gastrointestinal symptoms

    Time frame: 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

  3. Pulmonary symptoms

    Time frame: 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

  4. Health care utilization

    Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)

    frequency of hospital admissions

  5. Health care utilization

    Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)

    length of hospital admissions

  6. Health care utilization

    Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)

    rates of ER/urgent care visits

  7. GI medication use

    Time frame: 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

  8. Height

    Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)

    height

  9. Weight

    Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)

    Weight or weight for length

  10. Weight for height/body mass index (BMI)

    Time frame: 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)

  11. number of patients with unplanned G-tube exchange

    Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)

  12. urine output adequacy

    Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)

    frequency of urine output

  13. rate of respiratory suctioning per day

    Time frame: 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)

  14. need for antibiotics for pneumonitis

    Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)

    frequency of antibiotics prescribed for pulmonary indications

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jun 14, 2022
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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