Treatment Study of Metronidazole to Treat Dientamoebiasis in Children

Study Overview
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Brief Summary
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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.

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

Conditions
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Dientamoebiasis

Intervention / Treatment
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* Drug: Metronidazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with samples investigated at Statens Serum Institut. Faecal sample (index) positive for Dientamoeba fragilis (DF) by realtime PCR, within < 7 days. No faecal samples positive for DF within the period: 3 months prior to and up to index-sample. Telephone interview to parents no later then 14 days after result from index-sample. Age 3-12 years old. Place of residence: Island of Zealand, incl. capital region. Symptoms consistent with gastrointestinal infection of DF: Either 1) ≥ 2 episodes of diarrhea per week or 2) ≥ 2 episodes of stomach ache per week or 3) ≥ 2 of the following symptoms: Anorexia, Failure to thrive, Anal itching, excessive flatulence, other change in bowel movements. Exclusion Criteria: Expected non-compliance. Objection to subject participation from referring physician. Underlying illness or comorbidity, incl. known gastrointestinal illness (both infectious and non-infectious), but excluding constipation. Known liver disease or intolerance/allergy to metronidazole. Positive screening for other intestinal pathogens, which may explain subject symptoms. Treatment with metronidazole outside of study within study period. Weight > 50 kg

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metronidazole<br>Active treatment. | Drug: Metronidazole<br>* Metronidazole, oral suspension, 40mg/ml. 1 treatment period of 40mg/kg/day for 10 days, 3 daily dosages. Administered by parents.<br>* Other names: ATC-code: P01AB01;|
| Placebo Comparator: Placebo<br>Passive treatment. | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 days after end of treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Sample collection 14 days after end of treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, parasite, intestinal, treatment, RCT