Gastrointestinal Dysmotility on Aspiration Risk
RecruitingPhase 4
The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms
Who can join
Ages 5 to 21 · All sexes
Full eligibility criteria
Inclusion Criteria: 1. are 5-21 years of age; 2. receive \>90% of their calories by enteral tube (i.e., patients take no food or drink by mouth); 3. 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; 4. 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; 5. 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: 1. have progressive neurologic impairment; 2. have a history of prior intact Nissen fundoplication; 3. are currently taking oral or inhaled antibiotics, including prophylactic antibiotics; 4. are currently taking or have taken in the last four weeks acid suppression (H2 antagonist or PPI); or 5. are fed by gastrojejunostomy rather than by gastrostomy. -
About the study
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.
What is being tested
- Prucalopride (drug)
- Famotidine (drug)
Sponsor: Boston Children's Hospital · Participants: 120 · Started: Feb 13, 2025
Contact the study team
- Rachel Rosen, MD · Phone: 617-355-0897
Official record on ClinicalTrials.gov — NCT05455359
Locations in the U.S.
| Massachusetts | Boston Children's Hospital, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.