A study into the effect of metronidazole treatment on infection with Dientamoeba fragilis in children in Denmark.

Conditions: Presumed symptomatic gastrointestinal infection with the protozoan Dientamoeba fragilis.
MedDRA version: 13.1Level: LLTClassification code 10006051Term: Bowel dysfunctionSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 13.1Level: PTClassification code 10016766Term: FlatulenceSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 13.1Level: LLTClassification code 10021907Term: Infectious diarrheaSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 13.1Level: LLTClassification code 10034453Term: Perianal itchingSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 13.1Level: PTClassification code 10017999Term: Gastrointestinal painSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 13.1Level: PTClassification code 10016165Term: Failure to thriveSystem Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 13.1Level: PTClassification code 10067720Term: Parasitic gastroenteritisSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

Registration Number: EUCTR2010-024657-36-DK

Lead Sponsor: Statens Serum Institut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

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.
•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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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