ClinicalTrials.gg
Sign In
RecruitingNCT05455359Updated Aug 3, 2026

Gastrointestinal Dysmotility on Aspiration Risk

A Phase 4 interventional study of Prucalopride and Famotidine in Esophageal Motility Disorders, Gastric Motor Dysfunction and Aspiration Pneumonia, sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 5 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-08-03.

Primary conditionGastroesophageal RefluxRegistry: Esophageal Motility DisordersReclassifiedWhy we changed it
Registry
Esophageal Motility Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Gastroesophageal Reflux
Why
  1. The study's listed conditions name Gastroesophageal Reflux, a narrower term within Esophageal Motility Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Boston Children's Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
5 Years to 21 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Browse trials for

03

In context

Gastroesophageal Reflux Reclassified

1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.

This study's planned enrollment of 120 is above the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.

Browse Boston Children's Hospital studies →

Compared within Gastroesophageal Reflux, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Esophageal Motility Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
5 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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. -
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
120 participants (estimated)

Study 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

    Drug: Prucalopride · Drug: 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

    Drug: Prucalopride · Drug: Famotidine

Interventions

06

What researchers measure

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

    Time frame: 4 weeks

Secondary outcomes

  1. Gastric emptying outcomes

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

    Time frame: 4 weeks

  2. 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

    Time frame: 8 weeks

  3. Aspiration symptoms

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

    Time frame: 4 weeks

  4. Microbiome

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

    Time frame: 8 weeks

  5. Pneumonias

    Comparisons in the number of aspiration pneumonias between each treatment period

    Time frame: 10 weeks

  6. Esophageal reflux events

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

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2025 (actual). Primary completion is estimated for May 2027, 27 months after the start.

Of 30 phase 4 interventional studies under Gastroesophageal Reflux, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 27 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2022
First posted
Jul 13, 2022
StartActual
Feb 13, 2025
Primary completionEst.
May 31, 2027
CompletionEst.
May 31, 2027
Last update
Aug 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05455359
Lead sponsor
Boston Children's Hospital
Responsible party
Rachel Rosen (Associate Professor of Pediatrics, Boston Children's Hospital) — Principal investigator
First posted
Jul 13, 2022
Start date
Feb 13, 2025
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Aug 3, 2026

Study contacts

Rachel Rosen, MD
Contact
rachel.rosen@childrens.harvard.edu
617-355-0897

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Prucalopride · Famotidine

Other studies in this condition

Gastroesophageal Reflux →

Other studies from this sponsor

Boston Children's Hospital →

Start the discussion