Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea

August 26, 2014 updated by: Prof. Eli Schwartz MD, DTMH, Sheba Medical Center
Study hypotheses is that Antiparasitic therapy in patients with chronic diarrhea after travel to a developing country, with a negative stool findings, will be significantly effective in eliminating diarrhea and other gastro-intestinal complaints compared to similar patients receiving placebo.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It is common to encounter travelers from developing countries who suffer from persistent diarrhea after returning home. In many cases repeated stool samples are negative for bacteria, parasites and helminthes and the cause of the diarrhea is not found.

The main debate is whether this condition is a persistent parasitic infection (unidentified) or post-infectious irritable bowel syndrome.However, clinical experience suggests that some of these travelers respond to antiparasitic therapy.

This study aims to answer the question whether antiparasitic treatment in these cases is beneficial.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Not yet recruiting
        • Chaim Sheba Medical Center, Tel Hashomer, Israel
        • Contact:
      • Ramat-Gan, Israel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diarrhea (3 or more soft stools per day) for at least two weeks after a trip to a developing country in the past year
  • Stool sample negative for bacteria, parasites and helminthes at least once
  • Has not received, until now, antiparasitic or antihelminthic therapy

Exclusion Criteria:

  • Bloody diarrhea
  • Fever during enrolment 5. Allergy to the offered medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo arm

2 placebo pills X2 /day for 2 days followed by

1 placebo Pill X2 / day for 7 days
Drug: Placebo control

2 placebo pills X2 /day for 2 days followed by

1 placebo Pill X2 / day for 7 days
Experimental: Tinidazole and Albendazole treatment
Tinidazole 1 gram BID for 2 days followed by Albendazole 400mg BID for 7 days
Drug: Tinidazole and Albendazole
Tinidazole 2 gr/daily for 2 days followed by Albendazole 400mg X2 /day for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
improvement in gastrointestinal complaints
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 15, 2010

First Submitted That Met QC Criteria

February 17, 2010

First Posted (Estimate)

February 18, 2010

Study Record Updates

Last Update Posted (Estimate)

August 27, 2014

Last Update Submitted That Met QC Criteria

August 26, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-08-5059-ES-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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