Gastrointestinal Dysmotility on Aspiration Risk

Boston Children's Hospital

Status and phase: Enrolling; Phase 4

Conditions: Gastro Esophageal Reflux; Esophageal Motility Disorders; Aspiration Pneumonia; Gastric Motor Dysfunction

Treatments: Drug: Famotidine; Drug: Prucalopride

Study type: Interventional

Funder types: Other

Identifiers

NCT05455359

IRB-P00038381

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 5 to 21 years old

Volunteers: No Healthy Volunteers

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.

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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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Arm 1

Experimental group

Description:

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

Treatment:

Drug: Prucalopride

Drug: Famotidine

Arm 2

Experimental group

Description:

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

Treatment:

Drug: Prucalopride

Drug: Famotidine