Diverticulitis
Conditions
Keywords
Recurrent acute diverticulitis, Prevention, Diverticular complications, Rifaximin delayed release, Diverticulitis, SIBO
Brief summary
Colonic microbiota changes may play a key role in the pathogenesis of acute diverticulitis. A previous proof-of-concept study suggests that rifaximin, a low-absorbable oral antibiotic, may be beneficial for prevention of acute diverticulitis recurrence by modulating the gut microflora. The main objective of this study is to evaluate the safety and efficacy of two different doses of a delayed release formulation of rifaximin, versus placebo, for the prevention of recurrence of acute diverticulitis and diverticular complications in patients with a recent episode of acute diverticulitis.
Interventions
DRUGRifaximin delayed released 400mg Tablet
Rifaximin delayed released
OTHERPlacebo
Placebo BID + Placebo BID
Sponsors
Alfasigma S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This study is a phase II, multicenter, double-blind, placebo-controlled, randomized clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patients with recurrence of diverticulitis and/or diverticular complications over the 12-month treatment period. | 12-month treatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of emergency surgery for diverticulitis | 12-month treatment period | — |
| Rate of any hospitalization for diverticulitis | 12-month treatment period | — |
| Rate of hospitalization for diverticulitis without surgery | 12-month treatment period | — |
| 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 | — |
| Rate of elective surgery for diverticulitis | 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 |
| Change in Quality of Life | 12-month treatment period | Evaluated by SF36 Quality of Life Questionnaire |
| Left-lower quadrant abdominal pain duration | 12-month treatment period | — |
Countries
France, Germany, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed