Is it Effective to Treat Patients With Blastocystis Hominis Infection?

Sponsor

University of Lausanne Hospitals (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01521403

Collaborator

(none)

200

Enrollment

Location

Arms

121.9

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Blastocystis Hominis Infections	Drug: Metronidazole Drug: Placebo	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Is it Effective to Treat Patients With Blastocystis Hominis Infection? A Double-blind Placebo Controlled Randomized Trial

Actual Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Dec 31, 2018

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Metronidazole Metronidazole 3x500 mg per day for 10 days	Drug: Metronidazole 3x500 mg/day for 10 days
Placebo Comparator: Placebo Placebo 3x1 tablet per day for 10 days	Drug: Placebo 3x1 tablet per day for 10 days

Arm

Intervention/Treatment

Active Comparator: Metronidazole

Metronidazole 3x500 mg per day for 10 days

Drug: Metronidazole

3x500 mg/day for 10 days

Placebo Comparator: Placebo

Placebo 3x1 tablet per day for 10 days

Drug: Placebo

3x1 tablet per day for 10 days

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≥ 18 years
Gastrointestinal symptoms for more than 10 days
1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland	Lausanne	Vaud	Switzerland	1011

Sponsors and Collaborators

University of Lausanne Hospitals

Investigators

Principal Investigator: Serge de Valliere, MD, MSc, Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland