Immunohistology in USDD and Correlation Between Bacterial Flora and Phlogosis

Diverticular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068482
• Other study ID #: MDSNC2009
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2014
• Last updated: February 19, 2014
• Start date: November 2010
• Est. completion date: August 2012

Study information

• Verified date: February 2014
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: August 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diverticular Disease
• Diverticulum

Intervention

Drug:
• Rifaximin
Rifaximin 200 mg 6 tbs per day per 15 days/ month for 2 months

Locations

Country	Name	City	State
Italy	Cattholic University of the Sacre Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunohistological Pattern	Lymphocytes in peripheral Blood, Lymphocytes in the Sigmoid Mucosa, Lymphocytes in the Transverse Mucosa, Monocytes and Granulocytes in Peripheral Blood	Two months	No
Secondary	Clinical Symptoms	Dyspepsia, Meteorism, Abdominal pain, Tenesmus, Diarrhea, Fever, Fever with Chills, Painful Palpation, VAS, Likert, Numbers of Evacuations	Two Months	No