Treatment Study of Metronidazole to Treat Dientamoebiasis in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-06-30

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.

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Detailed Description

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Conditions

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Dientamoebiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Metronidazole

Active treatment.

Group Type EXPERIMENTAL

Metronidazole

Intervention Type DRUG

Metronidazole, oral suspension, 40mg/ml.

1 treatment period of 40mg/kg/day for 10 days, 3 daily dosages. Administered by parents.

Placebo

Passive treatment.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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Metronidazole

Metronidazole, oral suspension, 40mg/ml.

1 treatment period of 40mg/kg/day for 10 days, 3 daily dosages. Administered by parents.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Flagyl® (Metronidazole), oral suspension. Sanofi-aventis ATC-code: P01AB01

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No