Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea

Not Applicable

• Conditions: Chronic Diarrhea; Abdominal Pain; Bloating
• Interventions: Drug: Tinidazole and Albendazole; Drug: Placebo control

• Registration Number: NCT01070277
• Lead Sponsor: Sheba Medical Center

Brief 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.

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 Timeline

• Study First Submitted: 2010-02-15
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-18
• Study Start: 2012-03
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-26
• Last Update Posted: 2014-08-27
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tinidazole and Albendazole treatment	Tinidazole and Albendazole	Tinidazole 1 gram BID for 2 days followed by Albendazole 400mg BID for 7 days
Placebo arm	Placebo control	2 placebo pills X2 /day for 2 days followed by 1 placebo Pill X2 / day for 7 days

Primary Outcome Measures

Name	Time	Method
improvement in gastrointestinal complaints	3 months

Trial Locations

Locations (2)

Sheba Medical Center; 🇮🇱 Ramat-Gan, Israel

Chaim Sheba Medical Center, Tel Hashomer, Israel; 🇮🇱 Ramat Gan, Israel