Immunohistology in USDD and Correlation Between Bacterial Flora and Phlogosis

Phase 4

Completed

• Conditions: Diverticular Disease
• Interventions: Drug: Rifaximin

• Registration Number: NCT02068482
• Lead Sponsor: Catholic University of the Sacred Heart

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 Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2012-05
• Study Completion: 2012-08
• Status Verified: 2014-02
• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-19
• Last Update Submitted: 2014-02-19
• Study First Posted: 2014-02-21
• Last Update Posted: 2014-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1a USDD	Rifaximin	Rifaximin 200 mg 6 tbs per day per 15 days/ month for 2 months

Primary Outcome Measures

Name	Time	Method
Immunohistological Pattern	Two months	Lymphocytes in peripheral Blood, Lymphocytes in the Sigmoid Mucosa, Lymphocytes in the Transverse Mucosa, Monocytes and Granulocytes in Peripheral Blood

Secondary Outcome Measures

Name	Time	Method
Clinical Symptoms	Two Months	Dyspepsia, Meteorism, Abdominal pain, Tenesmus, Diarrhea, Fever, Fever with Chills, Painful Palpation, VAS, Likert, Numbers of Evacuations

Trial Locations

Locations (1)

Cattholic University of the Sacre Heart; 🇮🇹 Rome, Italy