Is it Effective to Treat Patients With Blastocystis Hominis Infection?

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Blastocystis Hominis Infections
• Intervention / Treatment: Drug: Metronidazole; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	10-14 days after treatment with Metronidazol

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Actual): December 31, 2018
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: January 25, 2012
• First Submitted That Met QC Criteria: January 27, 2012
• First Posted (Estimate): January 30, 2012

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Metronidazole; Blastocystis hominis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Diseases, Parasitic; Parasitic Diseases; Protozoan Infections; Amebiasis; Infections; Communicable Diseases; Blastocystis Infections; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: CVMV-Blastocystis hominis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No