Skip to main content
OpenTrials
Completed

NCT Number: NCT01314976

Treatment Study of Metronidazole to Treat Dientamoebiasis in Children

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dientamoebiasis Digestive System Diseases Gastrointestinal Diseases Infections Intestinal Diseases Intestinal Diseases, Parasitic Parasitic Diseases Protozoan Infections

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Statens Serum Institut

Copenhagen, 2300, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metronidazole

Drug

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

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Statens Serum Institut

Other

Registry information

Official study title

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

Acronym: DFPT

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 15, 2011
Registry last updated
Jun 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.