Assessment of Patients With Acute Pouchitis Treated With Antibiotics

Ki vehet részt

• Adult patients ≥ 18 years of age
• IPAA for UC (J-pouch only) ≥ 6 months prior to screening
• Diagnosis of acute pouchitis at screening by stool frequency (an absolute value of ≥ 6 stools / day AND an increase of ≥ 3 stools / day above the post-IPAA baseline), and local endoscopy (presence of ≥ 1 erosion or ulceration of the pouch on endoscopy [not including ulceration occurring within 1 cm of the pouch staple or pouch suture line])
• Not currently taking antibiotics for pouchitis or previous systemic antibiotic use for any reason within 4 weeks of screening. Prior to the Screening pouchoscopy. Note: Initiation of antibiotics for treatment of acute pouchitis prior to the Screening pouchoscopy will be permitted only if the participant initiates treatment within 48 hours prior to the Screening pouchoscopy; use outside of the 48-hour window will not be permitted and these patients should not be included in the study
• Current treatment with 5-aminosalicylic acid drugs, immunosuppressants, antidiarrheals, antimotility agents, and probiotics is permitted, if patient has received a stable dose for ≥ 4 weeks prior to screening. Dose of concomitant therapy must remain stable during the study period
• Able to participate fully in all aspects of this clinical trial
• Written informed consent must be obtained and documented

Ki nem vehet részt

• Antibiotic-dependent pouchitis, defined by ≥ 3 months of cumulative antibiotic use over the 12 months prior to screening
• Anticipated changes in therapy during study period
• Use of oral corticosteroids. Participants must have discontinued oral corticosteroids within 1 month prior to screening
• Current use of any advanced oral small molecule drug (e.g Janus kinase [JAK] inhibitors for the treatment of pouchitis. Participants must have discontinued oral small molecule therapy within 2 weeks prior to screening
• Failed (i.e., inadequate response with, loss of response to, or intolerance to) 2 or more compounds or classes of advanced therapies such as biologics and/or small molecule drugs (i.e., 1 biologic and 1 JAK inhibitor, 2 biologics in the same class, or 2 biologics from different classes) for the treatment of pouchitis
• Prior enrollment in the current study
• Pouchitis caused by other inflammatory etiologies (e.g., ischemia or infection)
• Known Crohn's disease (CD) or suspected CD of the pouch, defined as complex perianal/pouch fistula and/or extensive length of prepouch ileitis with deep ulceration
• Serious underlying disease other than acute pouchitis and UC that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study
• History of alcohol or drug abuse that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures
• Known history of allergy, intolerance, or are refractory to ciprofloxacin AND metronidazole AND any component of amoxicillin/potassium clavulanate combination
• Pouch formations besides J-pouch (e.g., W-, S- and Kock pouches)
• IPAA for familial adenomatous polyposis
• Isolated cuffitis, pouch-anal or pouch-ileal anastomotic stricture, perforating complications, or pelvic sepsis
• Participant who are pregnant or breastfeeding
• Unable to undergo endoscopic evaluation