BridgeMD
New treatment option for Esophageal Motility Disorders
Official title Gastrointestinal Dysmotility on Aspiration Risk
ClinicalTrials.gov ID: NCT05455359
What this study is testing
What is Prucalopride?
Prucalopride is an investigational medicine, being studied as a potential treatment for esophageal motility disorders.
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 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.
- 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's taking place
- 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 - 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?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.