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NCT Number: NCT05455359

Gastrointestinal Dysmotility on Aspiration Risk

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.

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Key information

Age range

5 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Rachel Rosen Principal Investigator

CONTACT

[email protected]

6173556055

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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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Exclusion criteria

  • have progressive neurologic impairment;
  • have a history of prior intact Nissen fundoplication;
  • are currently taking oral or inhaled antibiotics, including prophylactic antibiotics;
  • are currently taking or have taken in the last four weeks acid suppression (H2 antagonist or PPI); or
  • are fed by gastrojejunostomy rather than by gastrostomy. -

Treatment and study plan

prucalopride

Drug

Prucalopride 0.04 mg/kg/day

Famotidine

Drug

Famotidine 0.4 mg/kg/day

Primary outcomes

  1. Pediatric Cough Quality of Life Questionnaire

    Time frame: 4 weeks

    Comparison of the mean difference in the Pediatric Cough Quality of Life Questionnaire (range: 7 to 189, lower scores=more symptom impairment) between baseline and 4 week scores between Arm 1 and Arm 2

Secondary outcomes

  1. Gastric emptying outcomes

    Time frame: 4 weeks

    Comparison of within-patient differences in gastric residuals by nuclear scintigraphy

  2. Total Peds-GI QL score

    Time frame: 8 weeks

    Comparison of the mean difference in total Peds-GI QL scores (range: 0-100, lower=worse symptoms) between famotidine and prucalopride periods

  3. Aspiration symptoms

    Time frame: 4 weeks

    Comparison of the mean difference in the number of coughing or choking episodes per week during the fourth week of treatment

  4. Microbiome

    Time frame: 8 weeks

    Comparison of within-patient differences in microbiome diversity and abundance between baseline and after each medication period

  5. Pneumonias

    Time frame: 10 weeks

    Comparisons in the number of aspiration pneumonias between each treatment period

  6. Esophageal reflux events

    Time frame: 4 weeks

    Comparison of within-patient differences in post-prandial reflux events by nuclear scintigraphy

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Rosen, MD

CONTACT

[email protected]

617-355-0897

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 13, 2022
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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