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Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2014 by Sheba Medical Center.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Prof. Eli Schwartz MD, DTMH, Sheba Medical Center Identifier:
First received: February 15, 2010
Last updated: August 26, 2014
Last verified: August 2014
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 Intervention
Chronic Diarrhea
Abdominal Pain
Drug: Tinidazole and Albendazole
Drug: Placebo control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Sheba Medical Center:

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

Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01070277

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
  More Information

Responsible Party: Prof. Eli Schwartz MD, DTMH, Director, The Center of Geographic Medicine, Sheba Medical Center Identifier: NCT01070277     History of Changes
Other Study ID Numbers: SHEBA-08-5059-ES-CTIL
Study First Received: February 15, 2010
Last Updated: August 26, 2014

Keywords provided by Sheba Medical Center:
chronic diarrhea

Additional relevant MeSH terms:
Abdominal Pain
Signs and Symptoms, Digestive
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
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
Antitrichomonal Agents processed this record on April 28, 2017