Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-02 @ 2:01 AM
Study NCT ID:
NCT01521403
Status:
UNKNOWN
Last Update Posted:
2022-08-23
First Post:
2012-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is it Effective to Treat Patients With Blastocystis Hominis Infection?
Sponsor:
University of Lausanne Hospitals
Organization:
Study Overview
Official Title:
Is it Effective to Treat Patients With Blastocystis Hominis Infection? A Double-blind Placebo Controlled Randomized Trial
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: