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Gastrointestinal Dysmotility on Aspiration Risk

Primary Purpose

Esophageal Motility Disorders, Gastric Motor Dysfunction, Aspiration Pneumonia

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Prucalopride
Famotidine
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Motility Disorders

Eligibility Criteria

5 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. are 5-21 years of age;
  2. receive >90% of their calories by enteral tube (i.e., patients take no food or drink by mouth);
  3. are determined to be at high risk for aspiration pneumonia based on evidence of impaired airway protective mechanisms, documented by aspiration on video fluoroscopic swallow study;
  4. have static neurologic impairment, defined as functional and/or intellectual impairment that results from a chronic neurologic or related diagnosis (e.g., cerebral palsy) with no prospect of progression for at least one year;
  5. have chronic respiratory symptoms, defined as coughing, choking, or need for oral suctioning a minimum of three times per week during the prior four weeks.

    -

Exclusion Criteria:

  1. have progressive neurologic impairment;
  2. have a history of prior intact Nissen fundoplication;
  3. are currently taking oral or inhaled antibiotics, including prophylactic antibiotics;
  4. are currently taking or have taken in the last four weeks acid suppression (H2 antagonist or PPI); or
  5. are fed by gastrojejunostomy rather than by gastrostomy. -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Arm 1

    Arm 2

    Arm Description

    Patients will be undergo 1 week observation period followed by 4 weeks of prucalopride followed by 1 weeks of a wash out followed by 4 weeks of famotidine

    Patients will be undergo 1 week observation period followed by 4 weeks of famotidine followed by 1 weeks of a wash out followed by 4 weeks of prucalopride

    Outcomes

    Primary Outcome Measures

    Pediatric Cough Quality of Life Questionnaire
    Comparison of the mean difference in the Pediatric Cough Quality of Life Questionnaire (range: 7 to 189, lower scores=more symptom impairment) between baseline and 4 week scores between Arm 1 and Arm 2

    Secondary Outcome Measures

    Gastric emptying outcomes
    Comparison of within-patient differences in gastric residuals by nuclear scintigraphy
    Total Peds-GI QL score
    Comparison of the mean difference in total Peds-GI QL scores (range: 0-100, lower=worse symptoms) between famotidine and prucalopride periods
    Aspiration symptoms
    Comparison of the mean difference in the number of coughing or choking episodes per week during the fourth week of treatment
    Microbiome
    Comparison of within-patient differences in microbiome diversity and abundance between baseline and after each medication period
    Pneumonias
    Comparisons in the number of aspiration pneumonias between each treatment period
    Esophageal reflux events
    Comparison of within-patient differences in post-prandial reflux events by nuclear scintigraphy

    Full Information

    First Posted
    July 7, 2022
    Last Updated
    July 8, 2022
    Sponsor
    Boston Children's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05455359
    Brief Title
    Gastrointestinal Dysmotility on Aspiration Risk
    Official Title
    The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 18, 2022 (Anticipated)
    Primary Completion Date
    July 18, 2027 (Anticipated)
    Study Completion Date
    July 18, 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
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The hypothesis of this study is that esophageal and gastric dysmotility increase the risk of developing aspiration-associated symptoms in children with neurologic impairment. The investigators are conducting a ten week cross over study comparing prucalopride to famotidine for the treatment of aspiration-associated symptoms.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Motility Disorders, Gastric Motor Dysfunction, Aspiration Pneumonia, Gastro Esophageal Reflux

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Experimental
    Arm Description
    Patients will be undergo 1 week observation period followed by 4 weeks of prucalopride followed by 1 weeks of a wash out followed by 4 weeks of famotidine
    Arm Title
    Arm 2
    Arm Type
    Experimental
    Arm Description
    Patients will be undergo 1 week observation period followed by 4 weeks of famotidine followed by 1 weeks of a wash out followed by 4 weeks of prucalopride
    Intervention Type
    Drug
    Intervention Name(s)
    Prucalopride
    Intervention Description
    Prucalopride 0.04 mg/kg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Famotidine
    Intervention Description
    Famotidine 0.4 mg/kg/day
    Primary Outcome Measure Information:
    Title
    Pediatric Cough Quality of Life Questionnaire
    Description
    Comparison of the mean difference in the Pediatric Cough Quality of Life Questionnaire (range: 7 to 189, lower scores=more symptom impairment) between baseline and 4 week scores between Arm 1 and Arm 2
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Gastric emptying outcomes
    Description
    Comparison of within-patient differences in gastric residuals by nuclear scintigraphy
    Time Frame
    4 weeks
    Title
    Total Peds-GI QL score
    Description
    Comparison of the mean difference in total Peds-GI QL scores (range: 0-100, lower=worse symptoms) between famotidine and prucalopride periods
    Time Frame
    8 weeks
    Title
    Aspiration symptoms
    Description
    Comparison of the mean difference in the number of coughing or choking episodes per week during the fourth week of treatment
    Time Frame
    4 weeks
    Title
    Microbiome
    Description
    Comparison of within-patient differences in microbiome diversity and abundance between baseline and after each medication period
    Time Frame
    8 weeks
    Title
    Pneumonias
    Description
    Comparisons in the number of aspiration pneumonias between each treatment period
    Time Frame
    10 weeks
    Title
    Esophageal reflux events
    Description
    Comparison of within-patient differences in post-prandial reflux events by nuclear scintigraphy
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: are 5-21 years of age; receive >90% of their calories by enteral tube (i.e., patients take no food or drink by mouth); are determined to be at high risk for aspiration pneumonia based on evidence of impaired airway protective mechanisms, documented by aspiration on video fluoroscopic swallow study; have static neurologic impairment, defined as functional and/or intellectual impairment that results from a chronic neurologic or related diagnosis (e.g., cerebral palsy) with no prospect of progression for at least one year; have chronic respiratory symptoms, defined as coughing, choking, or need for oral suctioning a minimum of three times per week during the prior four weeks. - Exclusion Criteria: have progressive neurologic impairment; have a history of prior intact Nissen fundoplication; are currently taking oral or inhaled antibiotics, including prophylactic antibiotics; are currently taking or have taken in the last four weeks acid suppression (H2 antagonist or PPI); or are fed by gastrojejunostomy rather than by gastrostomy. -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rachel Rosen, MD
    Phone
    617-355-0897
    Email
    rachel.rosen@childrens.harvard.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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