Related Experiment Video
Updated: Dec 17, 2025
Probiotic Studies in Neonatal Mice Using Gavage
Published on: January 27, 2019
Rectal Omeprazole in Infants With Gastroesophageal Reflux Disease: A Randomized Pilot Trial
Petra Bestebreurtje1, Barbara A E de Koning2, Nel Roeleveld3
1Department of Clinical Pharmacology, Tergooi Hospital, Hilversum, The Netherlands.
Insights
Rectal omeprazole effectively increases infant gastric pH, similar to oral administration. This rectal route offers a promising alternative for infants with GERD due to EA or CDH, overcoming challenges with oral formulations.
Area of Science:
- Pediatric Gastroenterology
- Pharmacology
- Neonatal Medicine
Background:
- Infants often require acid suppression therapy with omeprazole for gastroesophageal reflux disease (GERD).
- Existing oral omeprazole formulations present challenges for infants due to difficulties in swallowing and potential damage to enteric coatings when altered for dosing.
- Infants with esophageal atresia (EA) or congenital diaphragmatic hernia (CDH) are particularly susceptible to GERD.
Purpose of the Study:
- To evaluate the efficacy and pharmacokinetics of rectally administered omeprazole in infants with EA or CDH-related GERD.
- To compare the effectiveness of rectal omeprazole administration with standard oral administration in this patient population.
Main Methods:
- A randomized study involving infants (6-12 weeks postnatal, >3 kg) diagnosed with EA or CDH and GERD.
- Infants received a single 1 mg/kg dose of omeprazole administered either rectally or orally.
- Primary outcome: percentage of infants achieving effective acid suppression based on 24-h intraesophageal pH monitoring.
Main Results:
- Omeprazole was effective in 56% of infants receiving rectal administration and 50% receiving oral administration.
- Both rectal and oral omeprazole significantly reduced reflux episodes and time, with statistically significant decreases in gastric pH.
- Serum exposure levels were comparable between infants who received omeprazole rectally and orally.
Conclusions:
- A single 1 mg/kg rectal dose of omeprazole effectively increases intraesophageal and gastric pH in infants with EA- or CDH-related GERD.
- Rectal omeprazole demonstrates efficacy comparable to oral administration.
- Rectal omeprazole presents an innovative and promising alternative for managing pathological GERD in infants, addressing limitations of current oral therapies.
Background And Objective:
Omeprazole is a proton pump inhibitor that is used in acid suppression therapy in infants. Infants cannot swallow the oral tablets or capsules. Since, infants require a non-standard dose of omeprazole, the granules or tablets are often crushed or suspended in water or sodium bicarbonate, which may destroy the enteric coating. In this study we explore the efficacy and pharmacokinetics of rectally administered omeprazole in infants with gastroesophageal reflux disease (GERD) due to esophageal atresia (EA) or congenital diaphragmatic hernia (CDH) and compare these with orally administered omeprazole.
Methods:
Infants (6-12 weeks postnatal and bodyweight > 3 kg) with EA or CDH and GERD were randomized to receive a single dose of 1 mg/kg omeprazole rectally or orally. The primary outcome was the percentage of infants for whom omeprazole was effective according to predefined criteria for 24-h intraesophageal pH. Secondary outcomes were the percentages of time that gastric pH was < 3 or < 4, as well as the pharmacokinetic parameters.
Results:
Seventeen infants, 4 with EA and 13 with CDH, were included. The proportion of infants for whom omeprazole was effective was 56% (5 of 9 infants) after rectal administration and 50% (4 of 8 infants) after oral administration. The total reflux time in minutes and percentages and the number of reflux episodes of pH < 4 decreased statistically significantly after both rectal and oral omeprazole administration. Rectal and oral administration of omeprazole resulted in similar serum exposure.
Conclusions:
A single rectal omeprazole dose (1 mg/kg) results in consistent increases in intraesophageal and gastric pH in infants with EA- or CDH-related GERD, similar to an oral dose. Considering the challenges with existing oral formulations, rectal omeprazole presents as an innovative, promising alternative for infants with pathological GERD.
Clinical Trial Register:
ClinicalTrials.gov Identifier: NCT00226044.
