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Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea

Primary Purpose

Chronic Diarrhea, Abdominal Pain, Bloating

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Tinidazole and Albendazole
Placebo control
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Diarrhea focused on measuring chronic diarrhea, travelers, Parasites, albendazole, tinidazole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chaim Sheba Medical Center, Tel Hashomer, Israel
  • Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo arm

Tinidazole and Albendazole treatment

Arm Description

2 placebo pills X2 /day for 2 days followed by 1 placebo Pill X2 / day for 7 days

Tinidazole 1 gram BID for 2 days followed by Albendazole 400mg BID for 7 days

Outcomes

Primary Outcome Measures

improvement in gastrointestinal complaints

Secondary Outcome Measures

Full Information

First Posted
February 15, 2010
Last Updated
August 26, 2014
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01070277
Brief Title
Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diarrhea, Abdominal Pain, Bloating
Keywords
chronic diarrhea, travelers, Parasites, albendazole, tinidazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
2 placebo pills X2 /day for 2 days followed by 1 placebo Pill X2 / day for 7 days
Arm Title
Tinidazole and Albendazole treatment
Arm Type
Experimental
Arm Description
Tinidazole 1 gram BID for 2 days followed by Albendazole 400mg BID for 7 days
Intervention Type
Drug
Intervention Name(s)
Tinidazole and Albendazole
Intervention Description
Tinidazole 2 gr/daily for 2 days followed by Albendazole 400mg X2 /day for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo control
Intervention Description
2 placebo pills X2 /day for 2 days followed by 1 placebo Pill X2 / day for 7 days
Primary Outcome Measure Information:
Title
improvement in gastrointestinal complaints
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Chaim Sheba Medical Center, Tel Hashomer, Israel
City
Ramat Gan
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eli Schwartz, MD
Phone
++97235308456
Email
elischwa@post.tau.ac.il
Facility Name
Sheba Medical Center
City
Ramat-Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eli Schwartz, M.D
Phone
+972-35308456
Email
Eli.schwartz@sheba.health.gov.il

12. IPD Sharing Statement

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Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea

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