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Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea

Information source: Sheba Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Diarrhea; Abdominal Pain; Bloating

Intervention: Tinidazole and Albendazole (Drug); Placebo control (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Sheba Medical Center

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.

Clinical Details

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

Primary outcome: improvement in gastrointestinal complaints

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Chaim Sheba Medical Center, Tel Hashomer, Israel, Ramat Gan, Israel; Not yet recruiting
Eli Schwartz, MD, Phone: ++97235308456, Email: elischwa@post.tau.ac.il

Sheba Medical Center, Ramat-Gan, Israel; Recruiting
Eli Schwartz, M.D, Phone: +972-35308456, Email: Eli.schwartz@sheba.health.gov.il

Additional Information

Starting date: March 2012
Last updated: August 26, 2014

Page last updated: August 23, 2015

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