Immunohistology in USDD and Correlation Between Bacterial Flora and Phlogosis

Catholic University of the Sacred Heart

Status and phase: Completed; Phase 4

Conditions: Diverticular Disease

Treatments: Drug: Rifaximin

Study type: Interventional

Funder types: Other

Identifiers

NCT02068482

MDSNC2009

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 3 patient groups

1a USDD

Active Comparator group

Description:

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

Treatment:

Drug: Rifaximin

1b USDD

No Intervention group

Description:

Patients control, no drug

Control group

No Intervention group

Description:

Control Group, no disease, no drug