NCT01521403

Is it Effective to Treat Patients With Blastocystis Hominis Infection?

Is it Effective to Treat Patients With Blastocystis Hominis Infection? A Double-blind Placebo Controlled Randomized Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Lausanne Hospitals · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine whether in the setting of primary health care it is effective to treat with metronidazole returning travellers with gastrointestinal symptoms and B. hominis in the stool or not.

Detailed description

Prevalence of B. hominis is between 30-50% in developing countries. Many travellers visit developing countries and are therefore at risk to be infected by this parasite. It's frequent that travellers return from developing countries with gastro-intestinal symptoms and approximately 10% of them have B. hominis as the sole parasite identified in the stools. Some anti-infective drugs, including metronidazole, trimethoprim-sulfamethoxazole and nitazoxanide, have shown to have activity against B. hominis, but there is still controversy about the pathogenic potential of B. hominis and there is no consensus about the indications for treatment. It is hypothesised that metronidazole is more effective than placebo in returning travellers with gastrointestinal symptoms and B. hominis as the sole intestinal parasite identified in the stool.

Conditions

• Blastocystis Hominis Infections

Interventions

Type	Name	Description
DRUG	Metronidazole	3x500 mg/day for 10 days
DRUG	Placebo	3x1 tablet per day for 10 days

Timeline

• Start date: 2012-11-01
• Primary completion: 2018-12-31
• Completion: 2022-12-30
• First posted: 2012-01-30
• Last updated: 2022-08-23

Locations

1 site across 1 country: Switzerland