An observational study in Diverticulitis, Colonic and Therapy, sponsored by Erasmo Spaziani. Recruiting at 12 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Erasmo Spaziani · Observational
The goal of this observational study is to assess the efficacy and safety of the probiotic Escherichia coli Nissle 1917 (EcN®, Ca.Di.Group S.p.A) in the treatment of symptomatic patients after an episode of both complicated and uncomplicated acute colonic diverticulitis.
The main question it aims to answer are:
27 studies on the registry are indexed under Diverticulitis, Colonic; 8 are open to participants now.
This study's planned enrollment of 145 is below the median of 250 across 15 observational studies indexed under Diverticulitis, Colonic.
Browse Diverticulitis, Colonic studies →This is the only study on the registry with Erasmo Spaziani as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The study population will include the above specified study groups.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients aged ≥18 with persistent symptoms at least three months after a radiologic and/or endoscopic documented acute diverticulitis or after six months of surgery for complicated acute diverticulitis. Therapy with Escherichia coli Nissle 1917 (EcN®) will be prescribed for a global duration of six months with the following assumption schedule: 2 capsules b.i.d. during 4 weeks, followed by 1 capsule o.i.d during 20 days each month for 5 months.
Drug: Probiotic Formula
Patients with asymptomatic diverticulosis. No therapy will be administered. Microbiota assessment will be performed.
Asymptomatic patients assessed three months after an episode of acute uncomplicated diverticulitis. No therapy will be administered. Microbiota assessment will be performed.
Asymptomatic patients assessed six months after an episode of acute complicated diverticulitis submitted to surgery with resection and without stoma . No therapy will be administered. Microbiota assessment will be performed.
Capsule with 25 billion live strains of Escherichia coli Nissle 1917
Also known as: Escherichia coli Nissle 1917
Median symptomatic score reduction after therapy with Escherichia coli Nissle 1917
Median symptomatic score assessed at baseline and during follow-up
Time frame: Six-months follow-up
Microbiota qualitative composition
Composition of microbiota will be assessed in all the study groups with a dedicated kit for collection.
Time frame: Baseline
Microbiota qualitative composition modification
Composition of microbiota will be assessed in symptomatic study groups with a dedicated kit for collection.
Time frame: Baseline and during 6-month follow-up.
Microbiota qualitative composition and median symptomatic score correlation
Correlation between the median symptomatic score and qualitative composition of microbiota modification after therapy.
Time frame: Baseline and during 6-month follow-up.
Concentration of fecal calprotectin
Assessment of fecal calprotectin concentration in the symptomatic study group.
Time frame: Baseline and during 6-month follow-up.
Bristol stool scale modification
Assessment of median Bristol stool scale in the symptomatic study group.
Time frame: Baseline and during 6-month follow-up.
Prevention of recurrent acute diverticulitis
Number off patients with recurrent acute diverticulitis.
Time frame: Six-month follow-up.
Safety
Number of patients with adverse events.
Time frame: Six-month follow-up.
Plan to share: No
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