Back to resultsGastrointestinal 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
About this trial
This is an interventional treatment trial for Esophageal Motility Disorders
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. -
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
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
Learn more about this trial
Gastrointestinal Dysmotility on Aspiration Risk
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