Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Diarrhea Abdominal Pain Bloating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo arm

2 placebo pills X2 /day for 2 days followed by

1 placebo Pill X2 / day for 7 days

Group Type PLACEBO_COMPARATOR

Placebo control

Intervention Type DRUG

2 placebo pills X2 /day for 2 days followed by

1 placebo Pill X2 / day for 7 days

Tinidazole and Albendazole treatment

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

Group Type EXPERIMENTAL

Tinidazole and Albendazole

Intervention Type DRUG

Tinidazole 2 gr/daily for 2 days followed by Albendazole 400mg X2 /day for 7 days

Interventions

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Tinidazole and Albendazole

Tinidazole 2 gr/daily for 2 days followed by Albendazole 400mg X2 /day for 7 days

Intervention Type DRUG

Placebo control

2 placebo pills X2 /day for 2 days followed by

1 placebo Pill X2 / day for 7 days

Intervention Type DRUG

Eligibility Criteria

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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