Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01070277

Enrollment

100

Registered

2010-02-18

Start date

2012-03-31

Completion date

2016-12-31

Last updated

2014-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Pain, Bloating, Chronic Diarrhea

Keywords

chronic diarrhea, travelers, Parasites, albendazole, tinidazole

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.

Interventions

DRUGTinidazole and Albendazole

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

DRUGPlacebo control

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
improvement in gastrointestinal complaints	3 months

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026