Esophageal Motility DisordersPhase 4NCT05455359
Gastrointestinal Dysmotility on Aspiration Risk
A Phase 4 study testing Prucalopride and Famotidine in people with Esophageal Motility Disorders and Gastric Motor Dysfunction, run by Boston Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Esophageal Motility Disorders, Gastric Motor Dysfunction, Aspiration Pneumonia
- What is being tested?
- Prucalopride and Famotidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2025to 31 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- -
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Rachel Rosen Principal Investigator, 6173556055, rachel.rosen@childrens.harvard.edu
About this study
Official title: The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms
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.
- Conditions
- Esophageal Motility Disorders, Gastric Motor Dysfunction, Aspiration Pneumonia, Gastro Esophageal Reflux
- Being tested
- Prucalopride, Famotidine
- Medical subject headings
- Esophageal Motility Disorders, Pneumonia, Aspiration, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrucaloprideDrug
Prucalopride 0.04 mg/kg/day
FamotidineDrug
Famotidine 0.4 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Prucalopride; Drug: 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 Receives: Drug: Prucalopride; Drug: Famotidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (6)
Gastric emptying outcomes
Comparison of within-patient differences in gastric residuals by nuclear scintigraphy
Measured: 4 weeks
Total Peds-GI QL score
Comparison of the mean difference in total Peds-GI QL scores (range: 0-100, lower=worse symptoms) between famotidine and prucalopride periods
Measured: 8 weeks
Aspiration symptoms
Comparison of the mean difference in the number of coughing or choking episodes per week during the fourth week of treatment
Measured: 4 weeks
Microbiome
Comparison of within-patient differences in microbiome diversity and abundance between baseline and after each medication period
Measured: 8 weeks
Pneumonias
Comparisons in the number of aspiration pneumonias between each treatment period
Measured: 10 weeks
Esophageal reflux events
Comparison of within-patient differences in post-prandial reflux events by nuclear scintigraphy
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start13 Feb 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Motility DisordersStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Rosen, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455359
- Sponsor's protocol ID
- IRB-P00038381
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2022
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms
- ClinicalTrials.gov ID
- NCT05455359
- Acronym / sponsor ID
- IRB-P00038381
- Conditions
- Esophageal Motility Disorders, Gastric Motor Dysfunction, Aspiration Pneumonia, Gastro Esophageal Reflux
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Prucalopride, Drug: FamotidinePatients 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 |
| Arm 2 | Experimental | Drug: Prucalopride, Drug: FamotidinePatients 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 |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrucalopridePrucalopride 0.04 mg/kg/day | Drug | Arm 1, Arm 2 |
| FamotidineFamotidine 0.4 mg/kg/day | Drug | Arm 1, Arm 2 |
Primary outcome
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
6 secondary outcomes
Gastric emptying outcomes
Time frame: 4 weeks
Total Peds-GI QL score
Time frame: 8 weeks
Aspiration symptoms
Time frame: 4 weeks
Microbiome
Time frame: 8 weeks
Pneumonias
Time frame: 10 weeks
Esophageal reflux events
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Esophageal Motility Disorders
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal Reflux Disease
Enrolling by invitation
Endoscopic Treatment of Gastroesophageal Reflux Disease
Gastro Esophageal Reflux Disease
Not yet recruitingObservational study
Gastroesophageal Reflux and Respiratory Function in Patients Undergoing Abdominoplasty
Abdominoplasty, Diaphragm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prucalopride and Famotidine in people with Esophageal Motility Disorders and Gastric Motor Dysfunction, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Rosen, MD (617-355-0897, rachel.rosen@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Cough Quality of Life Questionnaire (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.