Is it Effective to Treat Patients With Blastocystis Hominis Infection?

NCT ID: NCT01521403

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2022-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Metronidazole

Metronidazole 3x500 mg per day for 10 days

Group Type: ACTIVE_COMPARATOR

Metronidazole

Intervention Type: DRUG

3x500 mg/day for 10 days

Placebo

Placebo 3x1 tablet per day for 10 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

3x1 tablet per day for 10 days

Interventions

Metronidazole

3x500 mg/day for 10 days

Intervention Type: DRUG

Placebo

3x1 tablet per day for 10 days

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Serge de Valliere

MD, MSc, Consultant, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serge de Valliere, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland

Locations

Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

CVMV-Blastocystis hominis

Identifier Type: -

Identifier Source: org_study_id