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NCT01070277 Clinical Trial

Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea

Abdominal Pain Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01070277
Other study ID # SHEBA-08-5059-ES-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received February 15, 2010
Last updated August 26, 2014
Start date March 2012
Est. completion date December 2016

Study information
Verified date August 2014
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Tinidazole and Albendazole
Tinidazole 2 gr/daily for 2 days followed by Albendazole 400mg X2 /day for 7 days
• Placebo control
2 placebo pills X2 /day for 2 days followed by 1 placebo Pill X2 / day for 7 days

Locations
Country Name City State
Israel Chaim Sheba Medical Center, Tel Hashomer, Israel Ramat Gan
Israel Sheba Medical Center Ramat-Gan

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary improvement in gastrointestinal complaints 3 months No
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