NCT05455359

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
13mo left

Started Feb 2025

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Feb 2025May 2027

First Submitted

Initial submission to the registry

July 7, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
2.6 years until next milestone

Study Start

First participant enrolled

February 13, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

December 26, 2025

Status Verified

April 1, 2025

Enrollment Period

2.3 years

First QC Date

July 7, 2022

Last Update Submit

December 23, 2025

Conditions

Esophageal Motility DisordersAspiration PneumoniaGastro Esophageal RefluxGastric Motor Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Pediatric Cough Quality of Life Questionnaire

    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

    4 weeks

Secondary Outcomes (6)

  • Gastric emptying outcomes

    4 weeks

  • Total Peds-GI QL score

    8 weeks

  • Aspiration symptoms

    4 weeks

  • Microbiome

    8 weeks

  • Pneumonias

    10 weeks

  • +1 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Drug: PrucaloprideDrug: Famotidine

Arm 2

EXPERIMENTAL

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

Drug: PrucaloprideDrug: Famotidine

Interventions

PrucaloprideDRUG

Prucalopride 0.04 mg/kg/day

Arm 1Arm 2
FamotidineDRUG

Famotidine 0.4 mg/kg/day

Arm 1Arm 2

Eligibility Criteria

Age5 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Motility DisordersPneumonia, AspirationGastroesophageal Reflux

Interventions

prucaloprideFamotidine

Condition Hierarchy (Ancestors)

Deglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPneumoniaRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Rachel Rosen, MD

CONTACT

617-355-0897rachel.rosen@childrens.harvard.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 13, 2022

Study Start

February 13, 2025

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

December 26, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)