A Phase 4 interventional study of Metronidazole and Placebo in Dientamoebiasis, sponsored by Statens Serum Institut. Completed at 1 site in Denmark. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2013-06-26.
Sponsored by Statens Serum Institut · Phase 4, Interventional, and Treatment
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.
Statens Serum Institut is the lead sponsor of 28 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Active treatment.
Drug: Metronidazole
Passive treatment.
Drug: Placebo
Metronidazole, oral suspension, 40mg/ml. 1 treatment period of 40mg/kg/day for 10 days, 3 daily dosages. Administered by parents.
Also known as: Flagyl® (Metronidazole), oral suspension. Sanofi-aventis, ATC-code: P01AB01
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.
Overall gastrointestinal symptoms, day 14
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.
Time frame: 14 days after end of treatment period
Realtime PCR for D. fragilis, day 14
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.
Time frame: Sample collection 14 days after end of treatment period
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Dientamoebiasis
Statens Serum Institut