Gastrointestinal Dysmotility on Aspiration Risk

The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Motility Disorders; Gastro Esophageal Reflux; Aspiration Pneumonia; Gastric Motor Dysfunction
• Intervention / Treatment: Drug: Prucalopride; Drug: Famotidine

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rachel Rosen, MD; Phone Number: 617-355-0897; Email: rachel.rosen@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Rachel Rosen Principal Investigator; Phone Number: 6173556055; Email: rachel.rosen@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; 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	Drug: Prucalopride; Prucalopride 0.04 mg/kg/day; Drug: Famotidine; Famotidine 0.4 mg/kg/day
Experimental: Arm 2; 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	Drug: Prucalopride; Prucalopride 0.04 mg/kg/day; Drug: Famotidine; Famotidine 0.4 mg/kg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric emptying outcomes	Comparison of within-patient differences in gastric residuals by nuclear scintigraphy	4 weeks
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	8 weeks
Aspiration symptoms	Comparison of the mean difference in the number of coughing or choking episodes per week during the fourth week of treatment	4 weeks
Microbiome	Comparison of within-patient differences in microbiome diversity and abundance between baseline and after each medication period	8 weeks
Pneumonias	Comparisons in the number of aspiration pneumonias between each treatment period	10 weeks
Esophageal reflux events	Comparison of within-patient differences in post-prandial reflux events by nuclear scintigraphy	4 weeks

Collaborators and Investigators

• Sponsor: Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Digestive System Diseases; Gastrointestinal Diseases; Lung Diseases; Esophageal Diseases; Pneumonia; Deglutition Disorders; Gastroesophageal Reflux; Pneumonia, Aspiration; Esophageal Motility Disorders; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles; Famotidine; prucalopride
• Other Study ID Numbers: IRB-P00038381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No