Clinical Trial: Immunohistology in USDD and Correlation Between Bacterial Flora and Phlogosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Catholic University of the Sacred Heart

Current Primary Outcome: Immunohistological Pattern [ Time Frame: Two months ]

Lymphocytes in peripheral Blood, Lymphocytes in the Sigmoid Mucosa, Lymphocytes in the Transverse Mucosa, Monocytes and Granulocytes in Peripheral Blood


Original Primary Outcome: Same as current

Current Secondary Outcome: Clinical Symptoms [ Time Frame: Two Months ]

Dyspepsia, Meteorism, Abdominal pain, Tenesmus, Diarrhea, Fever, Fever with Chills, Painful Palpation, VAS, Likert, Numbers of Evacuations


Original Secondary Outcome: Same as current

Information By: Catholic University of the Sacred Heart

Dates:
Date Received: February 12, 2014
Date Started: November 2010
Date Completion:
Last Updated: February 19, 2014
Last Verified: February 2014