Is it Effective to Treat Patients With Blastocystis Hominis Infection?

Lausanne University Hospital (CHUV)

Status and phase: Active, not recruiting; Phase 4

Conditions: Blastocystis Hominis Infections

Treatments: Drug: Metronidazole; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01521403

CVMV-Blastocystis hominis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 18 years
• Gastrointestinal symptoms for more than 10 days
• B. hominis in any quantity in at least one stool specimen out of 3 examined
• No other pathogenic micro-organism identified

Exclusion criteria

• Fever > 37.5°
• bloody diarrhoea
• weight loss > 10% of usual body weight
• significant decrease of general condition
• oncological diseases
• immune deficiencies
• known chronic intestinal diseases
• use of anti-protozoan drugs in the last 2 weeks
• use of anti-coagulant treatment or antabuse
• pregnant and lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Metronidazole

Active Comparator group

Description:

Metronidazole 3x500 mg per day for 10 days

Treatment:

Drug: Metronidazole

Placebo

Placebo Comparator group

Description:

Placebo 3x1 tablet per day for 10 days

Treatment:

Drug: Placebo