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Immunohistology in USDD and Correlation Between Bacterial Flora and Phlogosis

Sponsor
Catholic University of the Sacred Heart (Other)
Overall Status
Completed
CT.gov ID
NCT02068482
Collaborator
(none)
61
Enrollment
1
Location
3
Arms
21
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Evaluation of Immunohistological Pattern in Patients With Uncomplicated Symptomatic Diverticular Disease and Correlation Between Intraluminal Bacterial Flora and Phlogosis
Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
Aug 1, 2012

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Clinical Symptoms [Two Months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cattholic University of the Sacre Heart Rome Italy 00168

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guido Costamagna, Director of Digestive and Surgical Endoscopy, Catholic University of the Sacred Heart
    ClinicalTrials.gov Identifier:
    NCT02068482
    Other Study ID Numbers:
    • MDSNC2009
    First Posted:
    Feb 21, 2014
    Last Update Posted:
    Feb 21, 2014
    Last Verified:
    Feb 1, 2014
    Keywords provided by Guido Costamagna, Director of Digestive and Surgical Endoscopy, Catholic University of the Sacred Heart
    Uncomplicated
    Symptomatic
    Additional relevant MeSH terms:
    Diverticular Diseases
    Diverticulum
    Rifaximin

    Study Results

    No Results Posted as of Feb 21, 2014