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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02068482

Enrollment

Registered

2014-02-21

Start date

2010-11-30

Completion date

2012-08-31

Last updated

2014-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diverticular Disease

Keywords

Uncomplicated, Symptomatic

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.

Interventions

DRUGRifaximin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026