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Determining the efficacy of proton pump inhibitors in the management of gastroenteritis-induced vomiting

Evaluation of the effectiveness of proton pump inhibitors (intravenous pantoprazole) in controlling vomiting in patients with acute gastroenteritis compared to fluid therapy and NPO

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241017063400N1
Enrollment
160
Registered
2025-01-04
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

acute gastroenteritis. Rotaviral enteritis

Interventions

Intervention 1: Intervention group: The administration of pantoprazole at a dose of 2 mg/kg/day, which is given intravenously in two doses. Each vial contains 40 mg of pantoprazole and is administered

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Months to 18 Years

Inclusion criteria

Inclusion criteria: age more than 4 months and less than 18 years old clinically diagnosed acute gastroenteritis patients with a mild to moderate degree of dehydration, where oral rehydration therapy has failed, and indication for hispitalization Oral feeding intolerance persistent vomiting despite ORT regimen ( one or more episodes of vomiting during the past 48 hours)

Exclusion criteria

Exclusion criteria: suspicion to acute abdomen history of any abdominal surgery Loss of contiousness fever history of metabolic disorder history of renal diseases, liver diseases, IBD, Immunodeficiency, DKA severe dehydration with or without shock Hypo/Hypernatremia dehydration corticosteroids consumption allergic history to PPT metabolic acidosis (Ph < 7.25) previous antibiotic use

Design outcomes

Primary

MeasureTime frame
The number of vomiting episodes within 24 hours after the start of treatment. Timepoint: Every 6 hours after the start of treatment. Method of measurement: According to the medical records and based on the number of episodes reported by nurses or the child’s parents within the specified time frame.

Secondary

MeasureTime frame
Severity of dehydration and its changes during treatment. Timepoint: Before starting the treatment and 24 hours after treatment. Method of measurement: Using dehydration indices (such as clinical symptoms, the child’s weight, and urine output).;Duration of hospital stay. Timepoint: From the start of hospitalization to the patient’s discharge (measured in hours or days). Method of measurement: Information recorded in the hospital records.;Adverse effects of the drug (gastrointestinal, allergic, etc.). Timepoint: Adverse effects of the drug (gastrointestinal, allergic, etc.). Method of measurement: Monitoring patient complaints, recording clinical side effects by nurses, and documenting reported adverse effects in the medical records.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNastaran Babajani

Tehran University of Medical Sciences

nastaran.ab@gmail.com+98 21 2223 8507

Outcome results

None listed

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