Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Prof. Eli Schwartz MD, DTMH, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01070277
First received: February 15, 2010
Last updated: August 26, 2014
Last verified: August 2014
  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:


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: 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.

  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
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 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   
Sheba Medical Center Recruiting
Ramat-Gan, Israel
Contact: Eli Schwartz, M.D    +972-35308456    Eli.schwartz@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
  More Information

No publications provided

Responsible Party: Prof. Eli Schwartz MD, DTMH, Director, The Center of Geographic Medicine, 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: August 26, 2014
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
Alkylating Agents
Anthelmintics
Anti-Infective Agents
Anticestodal Agents
Antimitotic Agents
Antineoplastic Agents
Antiparasitic Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Antitrichomonal Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014