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Diverticulosis of the colon is a frequent condition in adults in western countries and a significant number of patients experience clinical symptoms even when the diverticulosis is not complicated by diverticulitis.
Both central and mucosal immunity are altered in Uncomplicated Symptomatic Diverticular Disease (USDD) and Rifaximin ameliorate clinical symptoms and normalize the immunological abnormalities.
The Study Protocol is verify the modifications in the immunological pattern induced by reducing bacteria related activation of immunity by Rifaximin treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1a USDD | Active Comparator | Rifaximin 200 mg 6 tbs per day per 15 days/ month for 2 months |
|
| 1b USDD | No Intervention | Patients control, no drug | |
| Control group | No Intervention | Control Group, no disease, no drug |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin | Drug | Rifaximin 200 mg 6 tbs per day per 15 days/ month for 2 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunohistological Pattern | Lymphocytes in peripheral Blood, Lymphocytes in the Sigmoid Mucosa, Lymphocytes in the Transverse Mucosa, Monocytes and Granulocytes in Peripheral Blood | Two months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Symptoms | Dyspepsia, Meteorism, Abdominal pain, Tenesmus, Diarrhea, Fever, Fever with Chills, Painful Palpation, VAS, Likert, Numbers of Evacuations | Two Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franco Pandolfi, Professor | CU Sacred Heart | Principal Investigator |
| Lucio Petruzziello, Doctor | CU Sacred Heart | Study Chair |
| Paola Cesaro, Doctor | CU Sacred Heart | Study Chair |
| Rossella Cianci, Doctor | CU Sacred Heart | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cattholic University of the Sacre Heart | Rome | Italy | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25133198 | Derived | Cianci R, Frosali S, Pagliari D, Cesaro P, Petruzziello L, Casciano F, Landolfi R, Costamagna G, Pandolfi F. Uncomplicated diverticular disease: innate and adaptive immunity in human gut mucosa before and after rifaximin. J Immunol Res. 2014;2014:696812. doi: 10.1155/2014/696812. Epub 2014 Jul 16. |
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| ID | Term |
|---|---|
| D000076385 | Diverticular Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |