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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003986-42 |
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The aim of the study is to investigate the efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifaximin | Experimental |
| |
| Lactose | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin | Drug | 400 mg per day, oral use, maximum duration 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the prevention of travellers diarrhea with rifaximin by measurement of frequency and consistence of the stool. Diarrhea will be defined as passage of >2 unformed stools/24 hr plus one or more signs or symptoms of enteric infection. | From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany |
| Measure | Description | Time Frame |
|---|---|---|
| Documentation of adverse effects and tolerance of prophylaxis with rifaximin. | From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany | |
| Evaluation of prevention of post infectious irritable bowel syndrome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philipp G. Zanger, MD MSc DTM | Institute of Tropical Medicine, University Hospital of Tübingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Tropical Medicine, University Hospital of Tübingen | Tübingen | 72074 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24012319 | Result | Zanger P, Nurjadi D, Gabor J, Gaile M, Kremsner PG. Effectiveness of rifaximin in prevention of diarrhoea in individuals travelling to south and southeast Asia: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2013 Nov;13(11):946-54. doi: 10.1016/S1473-3099(13)70221-4. Epub 2013 Sep 4. |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Lactose | Drug | Coated Tablet, Oral Use |
|
| From the first day of the travel (travel period between 6 and 28 days) to 6 months after the subject's return to Germany |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |