Is it Effective to Treat Patients With Blastocystis Hominis Infection?

Blastocystis Hominis Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01521403
• Other study ID #: CVMV-Blastocystis hominis
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 2012
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2022
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 30, 2022
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blastocystis Hominis Infections
• Communicable Diseases
• Infections

Intervention

Drug:
• Metronidazole
3x500 mg/day for 10 days
• Placebo
3x1 tablet per day for 10 days

Locations

Country	Name	City	State
Switzerland	Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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