effect of omeprazole and es-omeprazole in reflux disease

Comparison of the effect of treatment with omeprazole and es-omeprazole in reflux disease (GERD) infants Lesser than one year old

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191027045256N1

Enrollment

Registered

2020-03-09

Start date

2019-10-07

Completion date

Unknown

Last updated

2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD. Gastro-esophageal reflux disease without esophagitis

Interventions

Intervention 1: Intervention group 1: Esomeprazole Abidi company,. Intervention 2: Intervention group 1: eprazole Abidi company.

Eligibility

Sex/Gender

All

Age

1 Months to 11 Months

Inclusion criteria

Inclusion criteria: Infants 1 to 11 months of age with clinical diagnosis of reflux based on symptoms or endoscopic evidence

Exclusion criteria

Exclusion criteria: Using a PPI in the last 7 days Treatment for reflux symptoms, including histamine 2 receptor antagonists, procinetics, and bismuth-containing antacids within 24 hours before intervention Patients with active gastrointestinal bleeding, apnea, allergic gastroenteritis, eosinophilic gastroenteritis, bleeding disorders, pyloric stenosis, active seizure disorder, acute pancreatitis or meningitis

Design outcomes

Primary

Measure	Time frame
Effect of Omeprazole and S-Omeprazole in Children. Timepoint: Symptoms evaluated included vomiting, contractility, irritability, hyper-esophageal and respiratory disorders (eg cough, wheezing / steroids) and nutritional problems (eg, dizziness / choking). 1 hour will be defined. Vomiting / regurgitation volume will be classified as small (5-15 ml), medium (15-30 ml), large (more than 30 ml) at any time of 4 weeks. Method of measurement: Recovery involves reducing the severity of symptoms to more than half of the initial symptom score (before the intervention).	—

Measure

Time frame

Effect of Omeprazole and S-Omeprazole in Children. Timepoint: Symptoms evaluated included vomiting, contractility, irritability, hyper-esophageal and respiratory disorders (eg cough, wheezing / steroids) and nutritional problems (eg, dizziness / choking). 1 hour will be defined. Vomiting / regurgitation volume will be classified as small (5-15 ml), medium (15-30 ml), large (more than 30 ml) at any time of 4 weeks. Method of measurement: Recovery involves reducing the severity of symptoms to more than half of the initial symptom score (before the intervention).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohamadali Sabahi

Kashan University of Medical Sciences

alisabahi1369@gmail.com+98 31 5557 8010

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026