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Is it Effective to Treat Patients With Blastocystis Hominis Infection?

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01521403
First Posted: January 30, 2012
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Serge de Valliere, University of Lausanne Hospitals
  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 Phase
Blastocystis Hominis Infections Drug: Metronidazole Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Serge de Valliere, University of Lausanne Hospitals:

Primary Outcome Measures:
  • Improvement of gastro-intestinal symptoms [ Time Frame: 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


Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521403


Locations
Switzerland
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
  More Information

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
First Submitted: January 25, 2012
First Posted: January 30, 2012
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Serge de Valliere, University of Lausanne Hospitals:
Blastocystis hominis
Metronidazole

Additional relevant MeSH terms:
Infection
Communicable Diseases
Blastocystis Infections
Intestinal Diseases, Parasitic
Parasitic Diseases
Amebiasis
Protozoan Infections
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents