Actively Recruiting
The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms in Children and Young Adults
Led by Boston Children's Hospital · Updated on 2025-12-26
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of esophageal and gastric dysmotility on the risk of aspiration-associated symptoms in children and young adults aged 5 to 21 with neurologic impairment. The study aims to understand how these digestive issues may contribute to symptoms like coughing and choking related to aspiration pneumonia. This is a Phase 4 randomized clinical trial sponsored by Boston Children's Hospital. Participants will undergo a ten-week crossover study involving two treatments: prucalopride and famotidine. The study begins with a one-week observation period, followed by four weeks of prucalopride treatment at a dose of 0.04 mg/kg/day, then a one-week washout period, and finally four weeks of famotidine at 0.4 mg/kg/day, or vice versa. This design allows comparison of the two drugs' effects on aspiration-associated symptoms. During the trial, participants will be closely monitored through various assessments including the Pediatric Cough Quality of Life Questionnaire after four weeks, gastric emptying tests, symptom tracking, microbiome analysis, pneumonia monitoring, and measurements of esophageal reflux events. The total participation lasts ten weeks with detailed observation of respiratory and gastrointestinal function to evaluate the treatments' impact on quality of life and aspiration risks.
CONDITIONS
Brief Title
Gastrointestinal Dysmotility on Aspiration Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 5 and 21 years
- Receive more than 90% of calories via enteral tube feeding
- High risk for aspiration pneumonia confirmed by video fluoroscopic swallow study
- Have a stable neurologic impairment with no progression expected for at least one year
- Experience chronic respiratory symptoms such as coughing, choking, or oral suctioning at least three times per week for the last four weeks
You will not qualify if you...
- Progressive neurologic impairment
- History of prior intact Nissen fundoplication surgery
- Currently taking oral or inhaled antibiotics, including prophylactic use
- Currently taking or have taken acid suppression medication (H2 antagonist or PPI) in the last four weeks
- Feeding through gastrojejunostomy instead of gastrostomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants undergo 1 week of observation before starting treatment.
1 visit (in-person)
Duration - 4 weeks
Participants receive 4 weeks of either prucalopride or famotidine as part of the crossover treatment design.
Weekly visits for up to 4 weeks
Duration - 1 week
Participants have a 1 week washout period between treatments to clear the first medication before starting the next.
1 visit (in-person)
Duration - 4 weeks
Participants receive 4 weeks of the alternate medication (famotidine or prucalopride) following the washout period.
Weekly visits for up to 4 weeks
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
R
Rachel Rosen, MD
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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