Clinical Trial: Is it Effective to Treat Patients With Blastocystis Hominis Infection?

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: University of Lausanne Hospitals

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Lausanne Hospitals

Dates:
Date Received: January 25, 2012
Date Started: November 2012
Date Completion: June 2018
Last Updated: May 10, 2017
Last Verified: May 2017