NCT05455359

Gastrointestinal Dysmotility on Aspiration Risk

The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Motility Disorders
• Gastric Motor Dysfunction
• Aspiration Pneumonia
• Gastro Esophageal Reflux

Interventions

Type	Name	Description
DRUG	Prucalopride	Prucalopride 0.04 mg/kg/day
DRUG	Famotidine	Famotidine 0.4 mg/kg/day

Timeline

• Start date: 2025-02-13
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2022-07-13
• Last updated: 2025-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study