Immunohistology in USDD and Correlation Between Bacterial Flora and Phlogosis

February 19, 2014 updated by: Guido Costamagna, Catholic University of the Sacred Heart

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Cattholic University of the Sacre Heart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1a USDD
Rifaximin 200 mg 6 tbs per day per 15 days/ month for 2 months
Drug: Rifaximin
Rifaximin 200 mg 6 tbs per day per 15 days/ month for 2 months
Other Names:
  • Normix
No Intervention: 1b USDD
Patients control, no drug
No Intervention: Control group
Control Group, no disease, no drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Symptoms
Time Frame: Two Months
Dyspepsia, Meteorism, Abdominal pain, Tenesmus, Diarrhea, Fever, Fever with Chills, Painful Palpation, VAS, Likert, Numbers of Evacuations
Two Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Investigators

  • Principal Investigator: Franco Pandolfi, Professor, CU Sacred Heart
  • Study Chair: Lucio Petruzziello, Doctor, CU Sacred Heart
  • Study Chair: Paola Cesaro, Doctor, CU Sacred Heart
  • Study Chair: Rossella Cianci, Doctor, CU Sacred Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 19, 2014

First Posted (Estimate)

February 21, 2014

Study Record Updates

Last Update Posted (Estimate)

February 21, 2014

Last Update Submitted That Met QC Criteria

February 19, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDSNC2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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