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Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01070277
First received: February 15, 2010
Last updated: February 17, 2010
Last verified: February 2010
History of Changes
  Purpose

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
Bloating
 Drug: Tinidazole and Albendazole
Drug: Placebo control

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • improvement in gastrointestinal complaints [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2010
Estimated Primary Completion Date: December 2011 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070277

Locations
Israel
Chaim Sheba Medical Center, Tel Hashomer, Israel Not yet recruiting
Ramat Gan, Israel
Contact: Eli Schwartz, MD     ++97235308456     elischwa@post.tau.ac.il    
Sponsors and Collaborators
Sheba Medical Center
  More Information

No publications provided

Responsible Party: Prof. Eli Schwartz, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01070277     History of Changes
Other Study ID Numbers: SHEBA-08-5059-ES-CTIL
Study First Received: February 15, 2010
Last Updated: February 17, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
chronic diarrhea
travelers
Parasites
albendazole
tinidazole

Additional relevant MeSH terms:
Abdominal Pain
Diarrhea
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Albendazole
Tinidazole
Antiparasitic Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Alkylating Agents
Antitrichomonal Agents

ClinicalTrials.gov processed this record on June 18, 2013