NCT01314976

Treatment Study of Metronidazole to Treat Dientamoebiasis in Children

Metronidazole for the Treatment of Dientamoebiasis in Children in Denmark - A Randomized, Placebo-controlled, Double-blinded Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Statens Serum Institut · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

Introduction: Dientamoeba fragilis (DF) is a commonly occurring intestinal protozoan that is considered a possible cause of infectious gastrointestinal disease in adults and children. DF has a particular high prevalence in children, and it is suspected that children present more symptoms in infection than adults. However, evidence of causality is lacking, treatment regimens are largely untested in controlled trials, and the most commonly used antibiotic against DF in Denmark, metronidazole, has never been tested against placebo. Main objective: To determine the clinical effect of metronidazole in DF-infected children with gastrointestinal complaints, where no other aetiology is known and no other gastrointestinal pathogens could be shown.

Conditions

• Dientamoebiasis

Interventions

Type	Name	Description
DRUG	Metronidazole	Metronidazole, oral suspension, 40mg/ml. 1 treatment period of 40mg/kg/day for 10 days, 3 daily dosages. Administered by parents.
DRUG	Placebo	Placebo. 1 treatment period of 1ml/kg/day for 10 days, 3 daily dosages. Administered by parents. Placebo formulation is identical to Flagyl® (Metronidazole), oral suspension from Sanofi-Aventis.

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-05-01
• Completion: 2013-06-01
• First posted: 2011-03-15
• Last updated: 2013-06-26

Locations

1 site across 1 country: Denmark