Actively Recruiting

Phase 4
Age: 5Years - 21Years
All Genders
NCT05455359

Gastrointestinal Dysmotility on Aspiration Risk

Led by Boston Children's Hospital · Updated on 2025-12-26

120

Participants Needed

1

Research Sites

119 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Gastrointestinal Dysmotility on Aspiration Risk

Who Can Participate

Age: 5Years - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be between 5 and 21 years of age
  • Receive more than 90% of calories by enteral tube and take no food or drink by mouth
  • Be at high risk for aspiration pneumonia based on impaired airway protection shown on video fluoroscopic swallow study
  • Have a stable neurologic impairment causing functional or intellectual disability with no progression expected for at least one year
  • Have chronic respiratory symptoms like coughing, choking, or need for oral suctioning at least three times per week during the last four weeks
Not Eligible

You will not qualify if you...

  • Have progressive neurologic impairment
  • Have had prior intact Nissen fundoplication surgery
  • Currently take oral or inhaled antibiotics, including prophylactic antibiotics
  • Currently take or have taken acid suppression medications (H2 antagonists or PPIs) in the last four weeks
  • Are fed by gastrojejunostomy instead of gastrostomy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

R

Rachel Rosen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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