Gastrointestinal Dysmotility on Aspiration Risk

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT05455359
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
5 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Prucalopride — DRUG
    Prucalopride 0.04 mg/kg/day
  • Famotidine — DRUG
    Famotidine 0.4 mg/kg/day

Study Details

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.

Key Dates

Start date
Feb 13, 2025
Status verified
Apr 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Experimental: 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

Primary Outcome Measure

Pediatric Cough Quality of Life Questionnaire [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Rachel Rosen Principal Investigator
[email protected]
6173556055

Find similar trials in Boston, MA

By research site
Boston Children's Hospital· Boston, MA

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