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

Phase 1
Completed
Conditions
Gastroesophageal Reflux symptom
Registration Number
TCTR20200415001
Lead Sponsor
Golestan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
62
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Gastroesophageal Reflux disease 4 month clinical symptoms of the patients
Secondary Outcome Measures
NameTimeMethod
Gastroesophageal Reflux disease 4 month abdominal pain, nausea, retrosternal pain, weight loss, poor appetite, dyspepsia, regurgitation, cou
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