Esophageal Motility Disorders study: Prucalopride vs Famotidine
Official title Gastrointestinal Dysmotility on Aspiration Risk
ClinicalTrials.gov ID: NCT05455359
What this study is testing
What is Prucalopride?
This is an investigational medicine being studied to see if it helps with swallowing and stomach movement problems in children with neurologic impairments. It is designed to stimulate specific receptors in the gut to help muscles move food and liquid along more effectively.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if problems moving food through the esophagus and stomach raise the chance of aspiration and to compare two medicines for treating those symptoms.
- Who it's for
- Children who have neurological problems and also have esophageal or gastric motility disorders.
- What's involved
- Participants will take one medicine for a period, then switch to the other medicine. They will have clinic visits and tests to track symptoms and safety.
- Time commitment
- The study lasts about ten weeks, with visits at the start, middle, and end of the treatment periods.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 21
You may be able to join 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...
- have static neurologic impairment, defined as functional and/or intellectual impairment that results from a chronic neurologic or related diagnosis...
- have chronic respiratory symptoms, defined as coughing, choking, or need for oral suctioning a minimum of three times per week during the prior four...
You likely can't join 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. -
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.