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Gastrointestinal Dysmotility on Aspiration Risk

NCT ID: NCT05455359

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-13

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Esophageal Motility Disorders Gastric Motor Dysfunction Aspiration Pneumonia Gastro Esophageal Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Prucalopride

Intervention Type DRUG

Prucalopride 0.04 mg/kg/day

Famotidine

Intervention Type DRUG

Famotidine 0.4 mg/kg/day

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

Group Type EXPERIMENTAL

Prucalopride

Intervention Type DRUG

Prucalopride 0.04 mg/kg/day

Famotidine

Intervention Type DRUG

Famotidine 0.4 mg/kg/day

Interventions

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Prucalopride

Prucalopride 0.04 mg/kg/day

Intervention Type DRUG

Famotidine

Famotidine 0.4 mg/kg/day

Intervention Type DRUG

Eligibility Criteria

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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. -
Minimum Eligible Age

5 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rachel Rosen

Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rachel Rosen, MD

Role: CONTACT

Phone: 617-355-0897

Email: [email protected]

Facility Contacts

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Rachel Rosen Principal Investigator

Role: primary

Other Identifiers

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IRB-P00038381

Identifier Type: -

Identifier Source: org_study_id