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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
193
Rifaximin delayed released
Placebo BID + Placebo BID
Hôpital Avicenne Service Gastro-entérologie
Bobigny, France
Cabinet Médical
Lille, France
Centre Hospitalier Regional Universitaire Claude Huriez Service de Chirurgie Digestive et Générale
Lille, France
Hôpital Saint-Joseph Service Hépato-Gastroentérologie
Marseille, France
CHU Nantes, Hôtel Dieu Clinique de Chirurgie digestive et endocrinienne (CCDE) Institut des maladies de l'Appareil Digestif (IMAD)
Nantes, France
Rate of patients with recurrence of diverticulitis and/or diverticular complications over the 12-month treatment period.
Time frame: 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]
Time frame: 12-month treatment period
Time to diverticulitis recurrence or complication
Time frame: 12-month treatment period
Rate of patients with diverticulitis-associated fever
Time frame: 12-month treatment period
Left-lower quadrant abdominal pain intensity
Time frame: 12-month treatment period
Left-lower quadrant abdominal pain duration
Time frame: 12-month treatment period
Number of days in a year with left-lower quadrant abdominal pain
Time frame: 12-month treatment period
Number of weeks in a year with episodes of prolonged (≥24 hours) left-lower quadrant abdominal pain
Time frame: 12-month treatment period
Number of days in a year with any abdominal pain
Time frame: 12-month treatment period
Number of weeks in a year with bloating
Time frame: 12-month treatment period
Change in bowel habits
Evaluated by Bristol Stool Scale
Time frame: 12-month treatment period
Rate of any hospitalization for diverticulitis
Time frame: 12-month treatment period
Rate of hospitalization for diverticulitis without surgery
Time frame: 12-month treatment period
Rate of elective surgery for diverticulitis
Time frame: 12-month treatment period
Rate of emergency surgery for diverticulitis
Time frame: 12-month treatment period
Change in Quality of Life
Evaluated by SF36 Quality of Life Questionnaire
Time frame: 12-month treatment period
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Hôpital Charles Nicolle - CHU Rouen Service Hépato-Gastroentérologie
Rouen, France
Centre Hospitalier Universitaire (CHU) de Strasbourg Service de Chirurgie Digestive et Endocrinienne
Strasbourg, France
Gemeinschaftspraxis - Praxis Überruhr
Essen, Germany
Medamed GmbH Studienambulanz Leipzig
Leipzig, Germany
MVZ Dres. Eisenbach, Simon, Schwarz
Leverkusen, Germany
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