Skip to main content
OpenTrials
Completed

NCT Number: NCT02068482

Immunohistology in USDD and Correlation Between Bacterial Flora and Phlogosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diverticular Disease Digestive System Diseases Diverticular Diseases Gastroenteritis Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cattholic University of the Sacre Heart

Rome, Italy, 00168

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rifaximin

Drug

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

Other names: Normix

Primary outcomes

  1. Immunohistological Pattern

    Time frame: Two months

    Lymphocytes in peripheral Blood, Lymphocytes in the Sigmoid Mucosa, Lymphocytes in the Transverse Mucosa, Monocytes and Granulocytes in Peripheral Blood

Secondary outcomes

  1. Clinical Symptoms

    Time frame: Two Months

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

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

Evaluation of Immunohistological Pattern in Patients With Uncomplicated Symptomatic Diverticular Disease and Correlation Between Intraluminal Bacterial Flora and Phlogosis

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 21, 2014
Registry last updated
Feb 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.