Diverticular DiseasePhase 4NCT02068482
Immunohistology in USDD and Correlation Between Bacterial Flora and Phlogosis
A Phase 4 study testing Rifaximin in people with Diverticular Disease, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticular Disease
- What is being tested?
- Rifaximin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2010to Aug 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 21Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Immunohistological Pattern in Patients With Uncomplicated Symptomatic Diverticular Disease and Correlation Between Intraluminal 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.
- Conditions
- Diverticular Disease
- Being tested
- Rifaximin
- Keywords
- Uncomplicated, Symptomatic
- Medical subject headings
- Diverticular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Also called Normix
Rifaximin 200 mg 6 tbs per day per 15 days/ month for 2 months
| Study group | Role | What they receive |
|---|---|---|
| 1a USDD | Active comparator | Rifaximin 200 mg 6 tbs per day per 15 days/ month for 2 months Receives: Drug: Rifaximin |
| 1b USDD | No intervention | Patients control, no drug |
| Control group | No intervention | Control Group, no disease, no drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunohistological Pattern
Lymphocytes in peripheral Blood, Lymphocytes in the Sigmoid Mucosa, Lymphocytes in the Transverse Mucosa, Monocytes and Granulocytes in Peripheral Blood
Measured: Two months
Secondary outcomes (1)
Clinical Symptoms
Dyspepsia, Meteorism, Abdominal pain, Tenesmus, Diarrhea, Fever, Fever with Chills, Painful Palpation, VAS, Likert, Numbers of Evacuations
Measured: Two Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startNov 2010
- Primary completionMay 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diverticular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Costamagna, Catholic University of the Sacred Heart
- Investigators
- Franco Pandolfi, Professor, Principal investigator, CU Sacred HeartLucio Petruzziello, Doctor, Study chair, CU Sacred HeartPaola Cesaro, Doctor, Study chair, CU Sacred HeartRossella Cianci, Doctor, Study chair, CU Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068482
- Sponsor's protocol ID
- MDSNC2009
- Status last verified
- Feb 2014
- First submitted
- 12 Feb 2014
- Last updated
- 21 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25133198
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunohistological Pattern in Patients With Uncomplicated Symptomatic Diverticular Disease and Correlation Between Intraluminal Bacterial Flora and Phlogosis
- ClinicalTrials.gov ID
- NCT02068482
- Acronym / sponsor ID
- MDSNC2009
- Conditions
- Diverticular Disease
- Keywords
- Uncomplicated, Symptomatic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1a USDD | Active comparator | Drug: RifaximinRifaximin 200 mg 6 tbs per day per 15 days/ month for 2 months |
| 1b USDD | No intervention | –Patients control, no drug |
| Control group | No intervention | –Control Group, no disease, no drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RifaximinAlso: NormixRifaximin 200 mg 6 tbs per day per 15 days/ month for 2 months | Drug | 1a USDD |
Primary outcome
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
1 secondary outcome
Clinical Symptoms
Time frame: Two Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2014.
- Derived from this study: PubMed 25133198Cianci 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.
Related trials for Diverticular Disease
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp
Enrolling by invitation
Transvaginal Diverticulum Wall Filling and Coverage Technique for Treating Female Circumferential Urethral Diverticulum
Circumferential Female Urethral Diverticulum
Not yet recruiting
Improving the Treatment of Acute Uncomplicated Diverticulitis in Routine Care
Diverticulitis
Not yet recruitingObservational study
Analysis of the Role of the Microbiota in Diverticular Disease
Diverticular Disease of Colon, Acute Diverticulitis
Recruiting
Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women
Isthmocele, Cesarean Scar Diverticula
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franco Pandolfi, Professor principal investigator
CU Sacred Heart
Lucio Petruzziello, Doctor study chair
CU Sacred Heart
Paola Cesaro, Doctor study chair
CU Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifaximin in people with Diverticular Disease, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunohistological Pattern (time frame: Two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02068482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2014.