Blastocystis Hominis Infections
Conditions
Keywords
Blastocystis hominis, Metronidazole
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.
Interventions
DRUGMetronidazole
3x500 mg/day for 10 days
DRUGPlacebo
3x1 tablet per day for 10 days
Sponsors
University of Lausanne Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of gastro-intestinal symptoms | 10-14 days after treatment with Metronidazol | The improvement of the following symptoms will be evaluated: * Presence of unusually soft or unformed stools in the last 3 days (yes or no) * Average number of stools per day in the last 3 days * Maximal abdominal pain in the last 3 days on a scale from 0-10 * Bloating in last 3 days on a scale from 0-10 * Flatulence in last 3 days on a scale from 0-10 |
Countries
Switzerland
Outcome results
None listed