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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metronidazole | Active Comparator | Metronidazole 3x500 mg per day for 10 days |
|
| Placebo | Placebo Comparator | Placebo 3x1 tablet per day for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole | Drug | 3x500 mg/day for 10 days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of gastro-intestinal symptoms | The improvement of the following symptoms will be evaluated:
| 10-14 days after treatment with Metronidazol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Serge de Valliere, MD, MSc | Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland | Lausanne | Canton of Vaud | 1011 | Switzerland |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 28, 2023 | |
| Reset | Feb 16, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 28, 2023 | Feb 16, 2024 |
| ID | Term |
|---|---|
| D016776 | Blastocystis Infections |
| ID | Term |
|---|---|
| D007411 | Intestinal Diseases, Parasitic |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000562 | Amebiasis |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Drug |
3x1 tablet per day for 10 days |
|
| D011528 |
| Protozoan Infections |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |