Immunohistology in USDD and Correlation Between Bacterial Flora and Phlogosis (NCT02068482) | Clinical Trial Compass
CompletedPhase 4
Immunohistology in USDD and Correlation Between Bacterial Flora and Phlogosis
Italy61 participantsStarted 2010-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.