Image

Gastrointestinal Dysmotility on Aspiration Risk

Gastrointestinal Dysmotility on Aspiration Risk

Recruiting
5-21 years
All
Phase 4

Powered by AI

Overview

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

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 details
    Esophageal Motility Disorders
    Gastric Motor Dysfunction
    Aspiration Pneumonia
    Gastro Esophageal Reflux

NCT05455359

Boston Children's Hospital

1 February 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.