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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo arm | Placebo Comparator | 2 placebo pills X2 /day for 2 days followed by 1 placebo Pill X2 / day for 7 days |
|
| Tinidazole and Albendazole treatment | Experimental | Tinidazole 1 gram BID for 2 days followed by Albendazole 400mg BID for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tinidazole and Albendazole | Drug | Tinidazole 2 gr/daily for 2 days followed by Albendazole 400mg X2 /day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| improvement in gastrointestinal complaints | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaim Sheba Medical Center, Tel Hashomer, Israel | Not yet recruiting | Ramat Gan | Israel |
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| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014011 | Tinidazole |
| D015766 | Albendazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Placebo control | Drug | 2 placebo pills X2 /day for 2 days followed by 1 placebo Pill X2 / day for 7 days |
|
| Sheba Medical Center | Recruiting | Ramat Gan | Israel |
|
| D012817 | Signs and Symptoms, Digestive |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |