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Treatment Study of Metronidazole to Treat Dientamoebiasis in Children

Information source: Statens Serum Institut
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dientamoebiasis

Intervention: Metronidazole (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Statens Serum Institut

Official(s) and/or principal investigator(s):
Dennis Röser, MD, Principal Investigator, Affiliation: Statens Serum Institut
Dennis Röser, MD, Study Director, Affiliation: Statens Serum Institut

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Overall gastrointestinal symptoms, day 14

Secondary outcome: Realtime PCR for D. fragilis, day 14

Eligibility

Minimum age: 3 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Statens Serum Institut, Copenhagen 2300, Denmark
Additional Information

Starting date: July 2011
Last updated: June 25, 2013

Page last updated: August 23, 2015

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