Treatment Study of Metronidazole to Treat Dientamoebiasis in Children (DFPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01314976
Recruitment Status : Completed
First Posted : March 15, 2011
Last Update Posted : June 26, 2013
Information provided by (Responsible Party):
Dennis Roser, 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.

Condition or disease Intervention/treatment Phase
Dientamoebiasis Drug: Metronidazole Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metronidazole for the Treatment of Dientamoebiasis in Children in Denmark - A Randomized, Placebo-controlled, Double-blinded Clinical Trial
Study Start Date : July 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Metronidazole
Active treatment.
Drug: Metronidazole

Metronidazole, oral suspension, 40mg/ml.

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

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

Placebo Comparator: Placebo
Passive treatment.
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.

Primary Outcome Measures :
  1. Overall gastrointestinal symptoms, day 14 [ Time Frame: 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 :
  1. Realtime PCR for D. fragilis, day 14 [ Time Frame: 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.

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01314976

Statens Serum Institut
Copenhagen, Denmark, 2300
Sponsors and Collaborators
Statens Serum Institut
Principal Investigator: Dennis Röser, MD Statens Serum Institut
Study Director: Dennis Röser, MD Statens Serum Institut

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dennis Roser, MD, PhD fellow, Statens Serum Institut Identifier: NCT01314976     History of Changes
Other Study ID Numbers: DSR-01
2010-024657-36 ( EudraCT Number )
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2013

Keywords provided by Dennis Roser, Statens Serum Institut:

Additional relevant MeSH terms:
Intestinal Diseases, Parasitic
Parasitic Diseases
Protozoan Infections
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents