Probiotic After Acute Colonic Diverticulitis

Study Overview
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Brief Summary
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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: Is the studied probiotic able to significantly reduce symptoms, assessed by means of a validated and dedicated score? Is there any difference in microbiota among the study group at baseline and a selected cohort of patients subdivided in subjects with diverticulosis and asymptomatic subjects after an episode of acute uncomplicated diverticulitis or an episode of complicated diverticulitis submitted to surgery with colonic resection without stoma? Is there any difference in microbiota in the study group at baseline and after 3 and 6 months of treatment with the probiotic? Is there any correlation between microbiota modification and symptoms during follow-up? Is there any impact on fecal calprotectin values before and during probiotic therapy? Is there any modification of evacuation before and during follow-up? Is probiotic able to prevent recurrent episodes of acute diverticulitis during follow-up? The safety of the probiotic will be assessed during the follow-up. The study group will be assessed at baseline and during follow-up with a dedicated clinical score and Bristol stool scale. Microbiota and fecal calprotectin values will be also assessed at baseline and during follow-up. Microbiota at baseline will be also evaluated for comparison in the three selected groups with diverticulosis and both asymptomatic and symptomatic after an episode of acute diverticulitis.

Official Title
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Probiotic EcN in Symptomatic Patients After an Episode of Acute Colonic Diverticulitis: a Prospective Multicentre Observational Study.

Conditions
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Diverticulitis, Colonic, Therapy

Intervention / Treatment
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* Drug: Probiotic Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic patients three months after an episode of uncomplicated acute colonic diverticulitis; Symptomatic patients six months after an episode of complicated acute colonic diverticulitis; submitted to .surgical colonic resection without stoma; Patients with diverticulosis; Asymptomatic patients three months after an episode of uncomplicated acute colonic diverticulitis; Asymptomatic patients six months after an episode of complicated acute colonic diverticulitis; submitted to surgical colonic resection without stoma. Exclusion Criteria: Ongoing acute diverticulitis at radiologic assessment Antibiotic therapy, both systemic and topic, and/or probiotics and/or mesalazine within four weeks before enrolment; Lactulose-lactitol use within four weeks before enrolment; Presence of chronic inflammatory bowel diseases; Presence of Segmental Colitis Associated with Diverticulitis (SCAD); Presence of ischemic colitis; Severe chronic liver (Child-Pugh C) and/or pancreatic and/or renal diseases; Patients with severe renal failure; Presence of suspected/actual pregnancy; Presence of recent/ongoing neoplasia, under oncological treatment within 6 months before enrolment; Presence of COVID-19 infection; Patients unable to give informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symptomatic patients after acute diverticulitis<br>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<br>* Capsule with 25 billion live strains of Escherichia coli Nissle 1917<br>* Other names: Escherichia coli Nissle 1917;|
| Diverticulosis<br>Patients with asymptomatic diverticulosis. No therapy will be administered. Microbiota assessment will be performed. | |
| Asymptomatic patients after acute uncomplicated diverticulitis<br>Asymptomatic patients assessed three months after an episode of acute uncomplicated diverticulitis. No therapy will be administered. Microbiota assessment will be performed. | |
| Asymptomatic patients after acute complicated diverticulitis<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median symptomatic score reduction after therapy with Escherichia coli Nissle 1917 | Median symptomatic score assessed at baseline and during follow-up | Six-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiota qualitative composition | Composition of microbiota will be assessed in all the study groups with a dedicated kit for collection. | Baseline | 
| Microbiota qualitative composition modification | Composition of microbiota will be assessed in symptomatic study groups with a dedicated kit for collection. | 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. | Baseline and during 6-month follow-up. | 
| Concentration of fecal calprotectin | Assessment of fecal calprotectin concentration in the symptomatic study group. | Baseline and during 6-month follow-up. | 
| Bristol stool scale modification | Assessment of median Bristol stool scale in the symptomatic study group. | Baseline and during 6-month follow-up. | 
| Prevention of recurrent acute diverticulitis | Number off patients with recurrent acute diverticulitis. | Six-month follow-up. | 
| Safety | Number of patients with adverse events. | Six-month follow-up. |