Is it Effective to Treat Patients With Blastocystis Hominis Infection?
Primary Purpose
Blastocystis Hominis Infections
Status
Active
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Metronidazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Blastocystis Hominis Infections focused on measuring Blastocystis hominis, Metronidazole
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
Sites / Locations
- Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Metronidazole
Placebo
Arm Description
Metronidazole 3x500 mg per day for 10 days
Placebo 3x1 tablet per day for 10 days
Outcomes
Primary Outcome Measures
Improvement of gastro-intestinal symptoms
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01521403
First Posted
January 25, 2012
Last Updated
August 22, 2022
Sponsor
University of Lausanne Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT01521403
Brief Title
Is it Effective to Treat Patients With Blastocystis Hominis Infection?
Official Title
Is it Effective to Treat Patients With Blastocystis Hominis Infection? A Double-blind Placebo Controlled Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2012 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blastocystis Hominis Infections
Keywords
Blastocystis hominis, Metronidazole
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metronidazole
Arm Type
Active Comparator
Arm Description
Metronidazole 3x500 mg per day for 10 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 3x1 tablet per day for 10 days
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
3x500 mg/day for 10 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3x1 tablet per day for 10 days
Primary Outcome Measure Information:
Title
Improvement of gastro-intestinal symptoms
Description
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
Time Frame
10-14 days after treatment with Metronidazol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge de Valliere, MD, MSc
Organizational Affiliation
Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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Is it Effective to Treat Patients With Blastocystis Hominis Infection?
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