Is it Effective to Treat Patients With Blastocystis Hominis Infection?

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Lausanne Hospitals
Sponsor:
Information provided by (Responsible Party):
Serge de Valliere, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01521403
First received: January 25, 2012
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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 Intervention
Blastocystis Hominis Infections
Drug: Metronidazole
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • Improvement of gastro-intestinal symptoms [ Time Frame: 10-14 days after treatment with Metronidazol ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521403

Contacts
Contact: Serge de Valliere, MD, MSc +41 21 314 48 52 serge.de-valliere@hospvd.ch

Locations
Switzerland
Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Serge de Valliere, MD, MSc    +41 21 314 48 52    serge.de-valliere@hospvd.ch   
Principal Investigator: Serge de Valliere, MD, MSc         
Sub-Investigator: Marie Laurent, Bachelor         
Principal Investigator: Blaise Genton, MD, PhD         
Sub-Investigator: Nicolas Senn, MD, PhD         
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
  More Information

No publications provided

Responsible Party: Serge de Valliere, MD, MSc, Consultant, Principal Investigator, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01521403     History of Changes
Other Study ID Numbers: CVMV-Blastocystis hominis
Study First Received: January 25, 2012
Last Updated: November 6, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Lausanne Hospitals:
Blastocystis hominis
Metronidazole

Additional relevant MeSH terms:
Amebiasis
Blastocystis Infections
Intestinal Diseases, Parasitic
Parasitic Diseases
Protozoan Infections
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metronidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on July 24, 2014