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Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

Primary Purpose

Feeding Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Extremely thick blenderized tube feed
Mildly thick blenderized tube feed
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Feeding Disorders

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick

    Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick

    Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick

    Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick

    Arm 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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Upper GI symptoms
    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
    Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Questionnaire, scale of 0 to 100, higher scores indicate less symptom burden
    Gastrointestinal symptoms
    Pediatric Quality of Life Inventory Gastroparesis Questionnaire, , scale of 0 to 100, higher scores indicate less symptom burden
    Pulmonary symptoms
    Pediatric Cough Questionnaire, score ranges from 0 to 25, higher scores indicate less symptom burden
    Health care utilization
    frequency of hospital admissions
    Health care utilization
    length of hospital admissions
    Health care utilization
    rates of ER/urgent care visits
    GI medication use
    % of participants requiring acid suppressive medication or GI motility agents such as cyproheptadine and erythromycin
    Height
    height
    Weight
    Weight or weight for length
    Weight for height/body mass index (BMI)
    weight for height (children < 2) or BMI (over 2 years of age)
    number of patients with unplanned G-tube exchange
    urine output adequacy
    frequency of urine output
    rate of respiratory suctioning per day
    how often suctioning is required (e.g. number of times per day)
    need for antibiotics for pneumonitis
    frequency of antibiotics prescribed for pulmonary indications

    Full Information

    First Posted
    June 7, 2022
    Last Updated
    May 15, 2023
    Sponsor
    Boston Children's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05417958
    Brief Title
    Clinical Trial of Blenderized Tube Feeds Varying in Viscosity
    Official Title
    A Novel N-of-1 Randomized, Controlled, Clinical Trial to Assess the Effect of Blenderized Tube Feeds on Esophagogastric Physiology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 15, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2027 (Anticipated)
    Study Completion Date
    June 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Boston Children's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Feeding Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    Extremely thick blenderized tube feed
    Intervention Description
    Commercial blenderized tube feed, not diluted
    Intervention Type
    Other
    Intervention Name(s)
    Mildly thick blenderized tube feed
    Intervention Description
    Commercial blenderized tube feed, diluted with ingredients contained in blend
    Primary Outcome Measure Information:
    Title
    Upper GI symptoms
    Description
    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
    Time Frame
    8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
    Secondary Outcome Measure Information:
    Title
    Gastrointestinal symptoms
    Description
    Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Questionnaire, scale of 0 to 100, higher scores indicate less symptom burden
    Time Frame
    8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
    Title
    Gastrointestinal symptoms
    Description
    Pediatric Quality of Life Inventory Gastroparesis Questionnaire, , scale of 0 to 100, higher scores indicate less symptom burden
    Time Frame
    8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
    Title
    Pulmonary symptoms
    Description
    Pediatric Cough Questionnaire, score ranges from 0 to 25, higher scores indicate less symptom burden
    Time Frame
    8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
    Title
    Health care utilization
    Description
    frequency of hospital admissions
    Time Frame
    8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
    Title
    Health care utilization
    Description
    length of hospital admissions
    Time Frame
    8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
    Title
    Health care utilization
    Description
    rates of ER/urgent care visits
    Time Frame
    8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
    Title
    GI medication use
    Description
    % of participants requiring acid suppressive medication or GI motility agents such as cyproheptadine and erythromycin
    Time Frame
    8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
    Title
    Height
    Description
    height
    Time Frame
    8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
    Title
    Weight
    Description
    Weight or weight for length
    Time Frame
    8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
    Title
    Weight for height/body mass index (BMI)
    Description
    weight for height (children < 2) or BMI (over 2 years of age)
    Time Frame
    8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
    Title
    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)
    Title
    urine output adequacy
    Description
    frequency of urine output
    Time Frame
    8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
    Title
    rate of respiratory suctioning per day
    Description
    how often suctioning is required (e.g. number of times per day)
    Time Frame
    8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
    Title
    need for antibiotics for pneumonitis
    Description
    frequency of antibiotics prescribed for pulmonary indications
    Time Frame
    8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

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