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The Efficacy of Baclofen to Treat Gastroesophageal Reflux disease in Children Aged 6 Months to 12 Years

The Efficacy of Baclofen to Treat Gastroesophageal Reflux disease in Children Aged 6 Months to 12 Years

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200415001
Enrollment
Unknown
Registered
2020-04-15
Start date
2019-05-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Gastroesophageal Reflux symptom

Interventions

intervention group received proton pump inhibitor (PPI) plus baclofen 0.25 mg per kg two times per day. ,The controls received only proton pump inhibitor 1 mg per kg treatment.
Experimental Drug,No Intervention Drug
intervention group ,control

Sponsors

Golestan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 12 Years

Inclusion criteria

Inclusion criteria: all children aged 6 months to 12 years with GERD who had at least two of the following five symptoms for at least one month. These symptoms included vomiting immediately after feeding, the persistence of reflux symptoms despite other treatments, restlessness after feeding for one to three hours, apnea and respiratory distress after feeding, no weight gain or weight gain of less than 500 grams, or weight loss during the last month and refusal to feed

Exclusion criteria

Exclusion criteria: patients less than 6 months and more than 12 years, patients taking baclofen for reasons other than GERD, patients with a history of anti-reflux surgery, patients with endoscopic evidence of Helicobacter pylori gastritis or eosinophilic esophagitis, patients with evidence of gastroparesis radiography and lack of parental consent to participate in the study

Design outcomes

Primary

MeasureTime frame
Gastroesophageal Reflux disease 4 month clinical symptoms of the patients

Secondary

MeasureTime frame
Gastroesophageal Reflux disease 4 month abdominal pain, nausea, retrosternal pain, weight loss, poor appetite, dyspepsia, regurgitation, cou

Countries

iran

Contacts

Public ContactMohammad Sobhani Shahmirzadi

Associate Professor, Pediatric Gastroenterologist, Neonatal and Children’s Health Research Center,

Sobhani_shahmirzadi@yahoo.com9801732451660

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026