Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
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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