Prucalopride vs Famotidine for Aspiration Pneumonia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how two treatments, prucalopride and famotidine, might reduce the risk of aspiration pneumonia in children with neurologic impairments. Aspiration pneumonia occurs when food or liquid is accidentally inhaled, leading to a lung infection. The study will compare how each medication affects symptoms such as coughing and choking. Children who primarily rely on a feeding tube, have long-term neurologic issues like cerebral palsy, and experience frequent respiratory symptoms may be suitable candidates for this trial. As a Phase 4 trial, this research involves FDA-approved treatments and aims to understand how they can benefit more patients.
Will I have to stop taking my current medications?
If you are currently taking oral or inhaled antibiotics or have taken acid suppression medications in the last four weeks, you cannot participate in the trial. The trial does not specify if you need to stop other medications, so it's best to discuss with the trial team.
What is the safety track record for these treatments?
Research shows that prucalopride is generally safe for both children and adults. An ongoing study is assessing its long-term safety in children, and so far, no major safety issues have emerged. In another study, prucalopride alleviated problems related to slow stomach emptying without causing serious side effects.
For famotidine, research indicates it is usually safe and doesn't cause severe problems. However, some studies suggest it might slightly increase the risk of pneumonia, especially with long-term use for acid reduction. Overall, famotidine is considered well-tolerated.
Both prucalopride and famotidine have been used previously, and current evidence supports their safety in humans. Always consult a doctor before joining a trial to understand how these findings might apply.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for aspiration pneumonia because they offer potential new approaches to managing the condition. Prucalopride, a selective serotonin 5-HT4 receptor agonist, is unique because it enhances gut motility, which might help prevent the buildup of substances that can be aspirated into the lungs. Famotidine, typically used for reducing stomach acid, is being explored for its potential anti-inflammatory benefits in the lungs. Unlike standard treatments that often focus solely on managing symptoms or using antibiotics, these drugs target underlying mechanisms that could reduce the risk of pneumonia development.
What evidence suggests that this trial's treatments could be effective for aspiration pneumonia?
This trial will compare Prucalopride and Famotidine for their effects on aspiration pneumonia. Research shows that Prucalopride, which participants in this trial may receive, can help the stomach empty its contents faster. This can reduce the chances of vomiting and the risk of stomach contents accidentally entering the lungs, which can lead to pneumonia. Prucalopride primarily treats long-term constipation by aiding gut movement.
Famotidine, another treatment option in this trial, reduces stomach acid. It often treats ulcers and acid reflux. Some studies suggest it might shorten hospital stays and lessen illness symptoms. However, strong evidence does not support its direct effect on reducing pneumonia risk.12678Are You a Good Fit for This Trial?
This trial is for children aged 5-21 with neurologic impairments who are at high risk for aspiration pneumonia, get most of their nutrition through a tube, and have chronic respiratory symptoms. They must show impaired swallowing on tests and not be expected to worsen neurologically within a year.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observation
Participants undergo a 1-week observation period before treatment
Treatment
Participants receive 4 weeks of prucalopride followed by a 1-week washout and then 4 weeks of famotidine, or vice versa
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Famotidine
- Prucalopride
Trial Overview
The study compares two drugs over ten weeks: Prucalopride versus Famotidine. It aims to see if these treatments can reduce the risk of aspiration-related issues in children with esophageal and gastric dysmotility due to neurological impairment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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
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
Famotidine is already approved in United States, European Union, Canada, Japan for the following indications:
- Gastroesophageal reflux disease (GERD)
- Zollinger-Ellison syndrome
- Peptic ulcer disease
- Gastroesophageal reflux disease (GERD)
- Zollinger-Ellison syndrome
- Peptic ulcer disease
- Gastroesophageal reflux disease (GERD)
- Zollinger-Ellison syndrome
- Peptic ulcer disease
- Gastroesophageal reflux disease (GERD)
- Zollinger-Ellison syndrome
- Peptic ulcer disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor
Citations
Use of acid-suppressive drugs and risk of pneumonia
A meta-analysis of the eight observational studies showed that the overall risk of pneumonia was higher among people using proton pump inhibitors.
Acid-Suppressive Medication Use and the Risk for Hospital ...
Acid-suppressive medication was ordered in 52% of admissions and hospital-acquired pneumonia occurred in 2219 admissions (3.5%). The unadjusted ...
A Clinical Trial - KnE Publishing
This study suggests that famotidine may be associated with more favorable clinical outcomes, including reduced. ICU length of stay and disease severity, ...
Famotidine - StatPearls - NCBI Bookshelf - NIH
Following oral administration, the onset of action occurs within 1 hour, with peak effects observed in 1 to 3 hours. Intravenous (IV) ...
The impact of proton pump inhibitor exposure on pneumonia
When analyzing by PPI types specifically, no significant differences in pneumonia rates were observed between the intervention and control ...
The efficacy and safety of acid suppressants for ...
The primary outcomes were clinically important gastrointestinal bleeding (CIGIB), hospital-acquired pneumonia (HAP), and in-hospital mortality.
Risk of Community-Acquired Pneumonia and Use ...
Conclusion Current use of gastric acid–suppressive therapy was associated with an increased risk of community-acquired pneumonia.
Use of acid-suppressive drugs and risk of pneumonia
• No data about risk of pneumonia n = 401. • Not ... The effects of cimetidine, ranitidine, and famotidine on human neutrophil functions.
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