Immunohistology in USDD and Correlation Between Bacterial Flora and Phlogosis
Evaluation of Immunohistological Pattern in Patients With Uncomplicated Symptomatic Diverticular Disease and Correlation Between Intraluminal Bacterial Flora and Phlogosis
1 other identifier
interventional
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 12, 2014
CompletedFirst Posted
Study publicly available on registry
February 21, 2014
CompletedFebruary 21, 2014
February 1, 2014
1.5 years
February 12, 2014
February 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immunohistological Pattern
Lymphocytes in peripheral Blood, Lymphocytes in the Sigmoid Mucosa, Lymphocytes in the Transverse Mucosa, Monocytes and Granulocytes in Peripheral Blood
Two months
Secondary Outcomes (1)
Clinical Symptoms
Two Months
Study Arms (3)
1a USDD
ACTIVE COMPARATORRifaximin 200 mg 6 tbs per day per 15 days/ month for 2 months
1b USDD
NO INTERVENTIONPatients control, no drug
Control group
NO INTERVENTIONControl Group, no disease, no drug
Interventions
Rifaximin 200 mg 6 tbs per day per 15 days/ month for 2 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cattholic University of the Sacre Heart
Rome, Italy, 00168, Italy
Related Publications (1)
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.
PMID: 25133198DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Digestive and Surgical Endoscopy
Study Record Dates
First Submitted
February 12, 2014
First Posted
February 21, 2014
Study Start
November 1, 2010
Primary Completion
May 1, 2012
Study Completion
August 1, 2012
Last Updated
February 21, 2014
Record last verified: 2014-02