COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01070277
Recruitment Status : Unknown
Verified August 2014 by Prof. Eli Schwartz MD, DTMH, Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : February 18, 2010
Last Update Posted : August 27, 2014
Information provided by (Responsible Party):
Prof. Eli Schwartz MD, DTMH, 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.

Condition or disease Intervention/treatment Phase
Chronic Diarrhea Abdominal Pain Bloating Drug: Tinidazole and Albendazole Drug: Placebo control Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

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

Primary Outcome Measures :
  1. improvement in gastrointestinal complaints [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01070277

Layout table for location information
Chaim Sheba Medical Center, Tel Hashomer, Israel Not yet recruiting
Ramat Gan, Israel
Contact: Eli Schwartz, MD    ++97235308456   
Sheba Medical Center Recruiting
Ramat-Gan, Israel
Contact: Eli Schwartz, M.D    +972-35308456   
Sponsors and Collaborators
Sheba Medical Center
Layout table for additonal information
Responsible Party: Prof. Eli Schwartz MD, DTMH, Director, The Center of Geographic Medicine, Sheba Medical Center Identifier: NCT01070277    
Other Study ID Numbers: SHEBA-08-5059-ES-CTIL
First Posted: February 18, 2010    Key Record Dates
Last Update Posted: August 27, 2014
Last Verified: August 2014
Keywords provided by Prof. Eli Schwartz MD, DTMH, Sheba Medical Center:
chronic diarrhea
Additional relevant MeSH terms:
Layout table for MeSH terms
Abdominal Pain
Signs and Symptoms, Digestive
Neurologic Manifestations
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Alkylating Agents
Anti-Bacterial Agents
Antitrichomonal Agents