Rifaximin Delayed Release for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications.

• Rifaximin delayed released 400mg Tablet (Drug), also known as Rifaximin-EIR: Rifaximin delayed released
• Placebo (Other): Placebo BID + Placebo BID

Primary outcomes

• Rate of patients with recurrence of diverticulitis and/or diverticular complications over the 12-month treatment period. [12-month treatment period]

Secondary outcomes

• Rate of patients with an acute episode of prolonged (≥24 hours) left-lower quadrant abdominal pain plus leukocytosis/elevation of CRP [Time Frame: 12-month treatment period] [12-month treatment period]
• Time to diverticulitis recurrence or complication [12-month treatment period]
• Rate of patients with diverticulitis-associated fever [12-month treatment period]
• Left-lower quadrant abdominal pain intensity [12-month treatment period]
• Left-lower quadrant abdominal pain duration [12-month treatment period]
• Number of days in a year with left-lower quadrant abdominal pain [12-month treatment period]
• Number of weeks in a year with episodes of prolonged (≥24 hours) left-lower quadrant abdominal pain [12-month treatment period]
• Number of days in a year with any abdominal pain [12-month treatment period]
• Number of weeks in a year with bloating [12-month treatment period]
• Change in bowel habits [12-month treatment period]: Evaluated by Bristol Stool Scale
• Rate of any hospitalization for diverticulitis [12-month treatment period]
• Rate of hospitalization for diverticulitis without surgery [12-month treatment period]
• Rate of elective surgery for diverticulitis [12-month treatment period]
• Rate of emergency surgery for diverticulitis [12-month treatment period]
• Change in Quality of Life [12-month treatment period]: Evaluated by SF36 Quality of Life Questionnaire

Sex: All, ages: 18 Years to 80 Years

Key Inclusion Criteria:

* Men and women aged 18-80 years at screening.
* Female participants must be either of non-childbearing potential or of childbearing potential with a negative pregnancy test result at screening and randomization AND agreeing to use a highly effective method of contraception.
* A previous documented episode of diverticulitis between 30 and 180 days prior to screening.
* Clinical remission from acute diverticulitis at screening

Key Exclusion Criteria:

* History of two or more acute diverticulitis episodes or history of any diverticular complication.
* Any documented current organic disease of the gastrointestinal tract other than diverticulosis
* Laboratory signs of clinically significant acute inflammation or signs/symptoms of diverticular complications.
* Diagnosis or history of inflammatory bowel disease (or other conditions associated with ulcerative lesions of the intestinal tract).
* Patients with positive Clostridium difficile toxin stool assay.
* Use of marketed rifaximin (or neomycin or other low-absorbable oral antibiotics) during or after the previous episode of acute diverticulitis.
* Severe hepatic impairment
* Severe kidney impairment
* Any other current significant health condition that in the Investigator's judgement may: i) jeopardize the patient's safe participation in the trial or ii) make unlikely the patient's completion of the study or iii) make unlikely the patient's compliance with the study procedures.
* History of hypersensitivity to rifaximin, rifamycin-derivatives or any of the rifaximin delayed release or placebo excipients.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply

• Alessandro Blè, MD, Study director, Alfasigma S.p.A.

NIH grants: 2017