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Immunohistology in USDD and Correlation Between Bacterial Flora and Phlogosis

Primary Purpose

Diverticular Disease

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Rifaximin
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diverticular Disease focused on measuring Uncomplicated, Symptomatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cattholic University of the Sacre Heart

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

No Intervention

Arm Label

1a USDD

1b USDD

Control group

Arm Description

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

Patients control, no drug

Control Group, no disease, no drug

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 12, 2014
Last Updated
February 19, 2014
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT02068482
Brief Title
Immunohistology in USDD and Correlation Between Bacterial Flora and Phlogosis
Official Title
Evaluation of Immunohistological Pattern in Patients With Uncomplicated Symptomatic Diverticular Disease and Correlation Between Intraluminal Bacterial Flora and Phlogosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticular Disease
Keywords
Uncomplicated, Symptomatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1a USDD
Arm Type
Active Comparator
Arm Description
Rifaximin 200 mg 6 tbs per day per 15 days/ month for 2 months
Arm Title
1b USDD
Arm Type
No Intervention
Arm Description
Patients control, no drug
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control Group, no disease, no drug
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
Normix
Intervention Description
Rifaximin 200 mg 6 tbs per day per 15 days/ month for 2 months
Primary Outcome Measure Information:
Title
Immunohistological Pattern
Description
Lymphocytes in peripheral Blood, Lymphocytes in the Sigmoid Mucosa, Lymphocytes in the Transverse Mucosa, Monocytes and Granulocytes in Peripheral Blood
Time Frame
Two months
Secondary Outcome Measure Information:
Title
Clinical Symptoms
Description
Dyspepsia, Meteorism, Abdominal pain, Tenesmus, Diarrhea, Fever, Fever with Chills, Painful Palpation, VAS, Likert, Numbers of Evacuations
Time Frame
Two Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Pandolfi, Professor
Organizational Affiliation
CU Sacred Heart
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lucio Petruzziello, Doctor
Organizational Affiliation
CU Sacred Heart
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paola Cesaro, Doctor
Organizational Affiliation
CU Sacred Heart
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rossella Cianci, Doctor
Organizational Affiliation
CU Sacred Heart
Official's Role
Study Chair
Facility Information:
Facility Name
Cattholic University of the Sacre Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25133198
Citation
Cianci R, Frosali S, Pagliari D, Cesaro P, Petruzziello L, Casciano F, Landolfi R, Costamagna G, Pandolfi F. Uncomplicated diverticular disease: innate and adaptive immunity in human gut mucosa before and after rifaximin. J Immunol Res. 2014;2014:696812. doi: 10.1155/2014/696812. Epub 2014 Jul 16.
Results Reference
derived

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Immunohistology in USDD and Correlation Between Bacterial Flora and Phlogosis

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