Recruiting

Prucalopride & Famotidine

Sponsor:

Boston Children's Hospital

Code:

NCT05455359

Conditions

Esophageal Motility Disorders

Gastric Motor Dysfunction

Aspiration Pneumonia

Gastro Esophageal Reflux

Eligibility Criteria

Sex: All

Age: 5 - 21

Healthy Volunteers: Not accepted

Interventions

Prucalopride

Famotidine

Study Details

Brief 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.

Conditions

Esophageal Motility Disorders

Gastric Motor Dysfunction

Aspiration Pneumonia

Gastro Esophageal Reflux

Study ID

NCT05455359

Start date

Feb 13, 2025

Status verified date

Jul, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 21

Healthy Volunteers: Not accepted

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. -

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Prucalopride

Prucalopride 0.04 mg/kg/day

Famotidine

Famotidine 0.4 mg/kg/day

Primary outcome measure

  • Pediatric Cough Quality of Life Questionnaire [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Rachel Rosen Principal Investigator

6173556055rachel.rosen@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-08-03.