Clinical Trial: Treatment Study of Metronidazole to Treat Dientamoebiasis in Children
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Metronidazole for the Treatment of Dientamoebiasis in Children in Denmark - A Randomized, Placebo-controlled, Double-blinded Clinical Trial
Brief 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.
Detailed Summary:
Sponsor: Statens Serum Institut
Current Primary Outcome: Overall gastrointestinal symptoms, day 14 [ Time Frame: 14 days after end of treatment period ]
All participants receive 10 days of treatment with study drug (placebo or active). Primary outcome measure is registered on day 14 after end of treatment, using a questionnaire for the parents of the study participant.
Measuring will be done using a VAS-score scale, addressing overall level of gastrointestinal symptoms in the previous 14 days. Results will be noted as a value from 0 to 10.
Original Primary Outcome: Same as current
Current Secondary Outcome: Realtime PCR for D. fragilis, day 14 [ Time Frame: Sample collection 14 days after end of treatment period ]
Secondary outcome measure will be registered using a specific realtime PCR for D. fragilis, performed on faecal samples collected from study-participant.
Results will be noted as either positive or negative.
Original Secondary Outcome: Same as current
Information By: Statens Serum Institut
Dates:
Date Received: March 14, 2011
Date Started: July 2011
Date Completion:
Last Updated: June 25, 2013
Last Verified: June 2013
