Gastrointestinal Dysmotility on Aspiration Risk

Phase 4

Not yet recruiting

• Conditions: Esophageal Motility Disorders; Gastric Motor Dysfunction; Gastro Esophageal Reflux; Aspiration Pneumonia
• Interventions: Drug: Prucalopride; Drug: Famotidine

• Registration Number: NCT05455359
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-08
• Last Update Submitted: 2022-07-08
• Study First Posted: 2022-07-13
• Last Update Posted: 2022-07-13
• Study Start: 2022-07-18
• Primary Completion: 2027-07-18
• Study Completion: 2027-07-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Prucalopride	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 1	Famotidine	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 2	Prucalopride	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
Arm 2	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

Primary Outcome Measures

Name	Time	Method
Pediatric Cough Quality of Life Questionnaire	4 weeks	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

Name	Time	Method
Gastric emptying outcomes	4 weeks	Comparison of within-patient differences in gastric residuals by nuclear scintigraphy
Aspiration symptoms	4 weeks	Comparison of the mean difference in the number of coughing or choking episodes per week during the fourth week of treatment
Microbiome	8 weeks	Comparison of within-patient differences in microbiome diversity and abundance between baseline and after each medication period
Pneumonias	10 weeks	Comparisons in the number of aspiration pneumonias between each treatment period
Total Peds-GI QL score	8 weeks	Comparison of the mean difference in total Peds-GI QL scores (range: 0-100, lower=worse symptoms) between famotidine and prucalopride periods
Esophageal reflux events	4 weeks	Comparison of within-patient differences in post-prandial reflux events by nuclear scintigraphy