Clinical trial NCT02068482: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diverticular Disease
Keywords: Uncomplicated
Symptomatic
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2014-02-21
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Immunohistological Pattern
timeFrame: Two months
Secondary outcomes:
measure: Clinical Symptoms
timeFrame: Two Months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Cattholic University of the Sacre Heart
Study officials:
affiliation: CU Sacred Heart
name: Franco Pandolfi, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: CU Sacred Heart
name: Lucio Petruzziello, Doctor
role: STUDY_CHAIR
affiliation: CU Sacred Heart
name: Paola Cesaro, Doctor
role: STUDY_CHAIR
affiliation: CU Sacred Heart
name: Rossella Cianci, Doctor
role: STUDY_CHAIR
References:
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.