Treatment Study of Metronidazole to Treat Dientamoebiasis in Children

Phase 4

Completed

• Conditions: Dientamoebiasis
• Interventions: Drug: Metronidazole; Drug: Placebo

• Registration Number: NCT01314976
• Lead Sponsor: Statens Serum Institut

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 Description

Not available

Study Timeline

• Study First Submitted: 2011-03-14
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Study Start: 2011-07
• Primary Completion: 2013-05
• Status Verified: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metronidazole	Metronidazole	Active treatment.
Placebo	Placebo	Passive treatment.

Primary Outcome Measures

Name	Time	Method
Overall gastrointestinal symptoms, day 14	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.

Secondary Outcome Measures

Name	Time	Method
Realtime PCR for D. fragilis, day 14	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.

Trial Locations

Locations (1)

Statens Serum Institut; 🇩🇰 Copenhagen, Denmark