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Cisapride in pediatric gastroesophageal reflux
R B Scott1, C Ferreira, L Smith
1Division of Pediatric Gastroenterology, University of Calgary, Canada.
Insights
Cisapride effectively reduced reflux episodes in infants, proving safe and well-tolerated. This prokinetic agent improved esophageal acid clearance in children under two with gastroesophageal reflux.
Area of Science:
- Pediatric Gastroenterology
- Pharmacology
Background:
- Gastroesophageal reflux is a prevalent condition in infants, potentially leading to severe complications.
- Daily regurgitant reflux affects many children, necessitating effective treatment options.
Purpose of the Study:
- To evaluate the efficacy and safety of oral cisapride suspension for treating infants and young children with daily regurgitant reflux.
- To assess cisapride's impact on esophageal acid clearance and reflux episode characteristics.
Main Methods:
- A randomized, prospective, double-blind, placebo-controlled trial involving 45 infants (6 weeks to 2 years old) over six weeks.
- Efficacy assessment included 24-hour esophageal pH monitoring, manometry, biopsy, and parental diaries.
- Safety was monitored through adverse events and laboratory tests.
Main Results:
- Cisapride significantly reduced the duration of upright and supine reflux episodes compared to placebo (p < 0.05).
- The drug significantly decreased the longest reflux episode duration from baseline.
- No significant differences were observed between cisapride and placebo for key metrics like pH < 4, episode count, or sphincter pressure.
Conclusions:
- Cisapride is a safe and well-tolerated prokinetic medication for children under two years old.
- The study demonstrates cisapride's ability to enhance esophageal clearance of refluxed gastric acid.
Background:
Gastroesophageal reflux is a common condition that in infants may lead to serious complication. This study assessed the efficacy and safety of oral cisapride suspension in the treatment of children 6 weeks to 2 years old with daily regurgitant reflux.
Methods:
A randomized, prospective, double-blind, placebo-controlled clinical trial was conducted at three study sites. After a 1 week baseline assessment, 45 infants 6 weeks to 2 years old were randomized to a double-blind trial in which they received a 6 week course of cisapride (0.2 mg/kg q6h) or a placebo suspension. Efficacy was assessed with 24 hour esophageal pH monitoring, esophageal manometry, and esophageal biopsy before and after the treatment period. A diary of regurgitation frequency and severity was kept by the parents. Safety was assessed by adverse event monitoring and standard laboratory measurements.
Results:
Compared with placebo, cisapride significantly (p < 0.05) reduced the mean duration of upright and supine reflux episodes. Compared to baseline, cisapride significantly reduced the mean duration of the longest reflux episode, and placebo increased the mean number of reflux episodes longer than 5 minutes. Cisapride was not significantly different from placebo for the following mean measurements: percent of total time pH < 4, number of reflux episodes, lower esophageal sphincter pressure, swallow pressure, regurgitation frequency or global evaluation scores.
Conclusions:
Cisapride is a safe, well tolerated prokinetic agent that improves the esophageal clearance of refluxed gastric acid in children under the age of 2 years.
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