NCT05455359 Gastrointestinal Dysmotility on Aspiration Risk
| NCT ID | NCT05455359 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Boston Children's Hospital |
| Condition | Esophageal Motility Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-02-13 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2025-02-13 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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. -
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05455359 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 21 Years, studying Esophageal Motility Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05455359 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05455359 currently recruiting?
Yes, NCT05455359 is actively recruiting participants. Contact the research team at rachel.rosen@childrens.harvard.edu for enrollment information.
Where is the NCT05455359 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05455359 clinical trial?
NCT05455359 is sponsored by Boston Children's Hospital. The trial plans to enroll 120 participants.