Gastric Dysmotility Clinical Trials

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The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 21
Healthy Volunteers: f
View:

• 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.

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Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Contact Information
Primary
Rachel Rosen, MD
rachel.rosen@childrens.harvard.edu
617-355-0897
Time Frame
Start Date: 2025-02-13
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 120
Treatments
Experimental: Arm 1
Patients will be undergo 1 week observation period followed by 4 weeks of prucalopride followed by 1 weeks of a wash out followed by 4 weeks of famotidine
Experimental: Arm 2
Patients will be undergo 1 week observation period followed by 4 weeks of famotidine followed by 1 weeks of a wash out followed by 4 weeks of prucalopride
Sponsors
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov

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