Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea

Sheba Medical Center

Status: Unknown

Conditions: Bloating; Chronic Diarrhea; Abdominal Pain

Treatments: Drug: Tinidazole and Albendazole; Drug: Placebo control

Study type: Interventional

Funder types: Other

Identifiers

NCT01070277

SHEBA-08-5059-ES-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Placebo arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo control

Tinidazole and Albendazole treatment

Experimental group

Description:

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

Treatment:

Drug: Tinidazole and Albendazole