Immunohistology in USDD and Correlation Between Bacterial Flora and Phlogosis

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Evaluation of Immunohistological Pattern in Patients With Uncomplicated Symptomatic Diverticular Disease and Correlation Between Intraluminal Bacterial Flora and Phlogosis

Conditions
-----------------
Diverticular Disease

Intervention / Treatment
-----------------
* Drug: Rifaximin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female age 18 or more radiologic or endoscopic diagnosis of diverticular disease located in sigma or colon descendent Informed consent patients willing to participate in to the study Exclusion Criteria: other colon diseases Inflammatory Bowel Diseases signs or symptoms of inflammation consumption of : antibiotics, anti-inflammatory drugs ( FANS and 5-ASA), prebiotics, Proton Pump Inhibitors, corticosteroids, fiber within three months pregnancy and breast feeding acute diverticulitis characterized by: moderate/sever pain in left iliac fossa fever > 38°C abdominal pain haematochezia leukocytosis (20% more than the normal range) remote acute diverticulitis rifaximin hypersensitivity neoplastic diseases immunodeficiencies poor physical conditions leaver deficiencies (Child C), kidney (Creatinine>2,2 mg/dl), heart (NYHA 3-4) major psychiatric illness drugs abuses and alcoholism participations in other clinical trials within 4 weeks patients unwillingness certificate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1a USDD<br>Rifaximin 200 mg 6 tbs per day per 15 days/ month for 2 months | Drug: Rifaximin<br>* Rifaximin 200 mg 6 tbs per day per 15 days/ month for 2 months<br>* Other names: Normix;|
| No Intervention: 1b USDD<br>Patients control, no drug | |
| No Intervention: Control group<br>Control Group, no disease, no drug | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uncomplicated, Symptomatic