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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Metronidazole, oral suspension, 40mg/ml. 1 treatment period of 40mg/kg/day for 10 days, 3 daily dosages. Administered by parents.
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.
Statens Serum Institut
Copenhagen, Denmark
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
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