Gastrointestinal Dysmotility on Aspiration Risk
Recruiting now · Phase 4
Conditions studied: Esophageal Motility Disorders, Gastric Motor Dysfunction, Aspiration Pneumonia, Gastro Esophageal Reflux
In brief
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.
Key facts
- Study ID
- NCT05455359
- Run by
- Boston Children's Hospital
- People needed
- 120
- Starts
- 2025-02-13
- Expected to finish
- 2027-05-31
- Last updated by the study team
- 2026-08-03
Who can join
Age: 5 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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. -
Where it is running
- Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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