Gastrointestinal Dysmotility on Aspiration Risk

Sponsor

Boston Children's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05455359

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Motility Disorders Gastric Motor Dysfunction Aspiration Pneumonia Gastro Esophageal Reflux	Drug: Prucalopride Drug: Famotidine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms

Anticipated Study Start Date :

Jul 18, 2022

Anticipated Primary Completion Date :

Jul 18, 2027

Anticipated Study Completion Date :

Jul 18, 2027

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Gastric emptying outcomes [4 weeks]
Comparison of within-patient differences in gastric residuals by nuclear scintigraphy
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
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
Esophageal reflux events [4 weeks]
Comparison of within-patient differences in post-prandial reflux events by nuclear scintigraphy

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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. -