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In a phase 4, double-blind, randomized trial, vedolizumab therapy was more effective than placebo in inducing remission in patients with chronic pouchitis after ileal pouch–anal anastomosis for ulcerative colitis.

Abstract Background In ulcerative colitis, a pouchitis is the most common long-term adverse effect after proctocolectomy and ileal pouch-anal anastomosis. Approximately 5% of patients develop chronic antibiotic-dependent or antibiotic-refractory pouchitis without any effective treatment. The aim of this trial was to investigate the efficacy and safety of fecal microbiota transplantation in the treatment of chronic pouchitis. Methods This was a single-center, double-blinded, parallel group trial comparing donor fecal microbiota transplantation with placebo (autologous transplant) in chronic pouchitis. Twenty-six patients were recruited at the Helsinki University Hospital between December 2017 and August 2018 and were randomly allocated a 1:1 ratio to either donor fecal microbiota transplantation or placebo. The protocol included 2 transplantations into the pouch on weeks 0 and 4, and patients were followed up for 52 weeks. Results Nine patients in the intervention group and 8 patients in the placebo group relapsed during the 52-week follow-up, and the relapse-free survival did not differ between the groups (P = 0.183, log-rank; hazard ratio, 1.90 [95% confidence interval, 0.73-4.98; P = 0.190]). In the subgroup analysis of patients using continuous antibiotics before the study, the relapse-free survival was shorter in the intervention group (P = 0.004, log-rank; hazard ratio, 13.08 [95% confidence interval, 1.47-116.60; P = 0.021]). No major adverse effects were reported. Conclusions The fecal microbiota transplantation treatment regime used in our study was not effective in the treatment of chronic pouchitis. The safety profile of fecal microbiota transplantation was good. ClinicalTrials.gov identifier NCT03378921.

Background This systematic review explored different medications and methods for prevention and treatment of pouchitis after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA). Methods PubMed, Scopus, and Web of Science were searched for randomized clinical trials that assessed prevention or treatment of pouchitis. The systematic review was reported in line with updated 2020 PRISMA guidelines. Risk of bias in the trials included was assessed using the ROB-2 tool and certainty of evidence was assessed using GRADE. The main outcomes were the incidence of new pouchitis episodes in the preventative studies and resolution or improvement of active pouchitis in the treatment studies. Results Fifteen randomized trials were included. A meta-analysis of 7 trials on probiotics revealed significantly lower odds of pouchitis with the use of probiotics (RR: 0.26, 95% CI: 0.16–0.42, I 2  = 20%, p  < 0.001) and similar odds of adverse effects to placebo (RR: 2.43, 95% CI: 0.11–55.9, I 2  = 0, p  = 0.579). One trial investigated the prophylactic role of allopurinol in preventing pouchitis and found a comparable incidence of pouchitis in the two groups (31% vs 28%; p  = 0.73). Seven trials assessed different treatments for active pouchitis. One recorded the resolution of pouchitis in all patients treated with ciprofloxacin versus 67% treated with metronidazole. Both budesonide enema and oral metronidazole were associated with similar significant improvement in pouchitis (58.3% vs 50%, p  = 0.67). Rifaximin, adalimumab, fecal microbiota transplantation, and bismuth carbomer foam enema were not effective in treating pouchitis. Conclusions Probiotics are effective in preventing pouchitis after IPAA. Antibiotics, including ciprofloxacin and metronidazole, are likely effective in treating active pouchitis.

Background Pouchitis is the most common complication after ileal pouch-anal anastomosis (IPAA) for ulcerative colitis. Induction and maintenance of remission is a crucial therapeutic goal. We investigated curcumin’s efficacy in treatment of pouchitis. Methods The double-blind trial included an induction cohort of refractory pouchitis patients and a maintenance cohort of patients without pouchitis after IPAA. Patients received either placebo or curcumin for 8 weeks. The pouchitis activity were assessed before and after and was compared between cohorts or groups. Laboratory inflammation indicators, nutritional status and quality of life were also appraised. Results 52 patients were included, with 39 and 13 patients entering the maintenance cohort and induction cohort, respectively. In maintenance cohort, the proportion of clinical remission elevated from 11 to 89% in curcumin group (p = 0.005), whereas there was no significant difference in placebo group (10% vs 5%, p = 1).In induction cohort, 67% (4/6) patients achieved clinical response after 8 weeks’ intervention of curcumin, whereas none treated with placebo ( p  = 0.021). Patients treated with curcumin appeared less inflammation and there was no significant difference in indicators changes between two cohorts. Conclusions Curcumin has preventive and therapeutic effects on pouchitis. Curcumin supplementation can reduce the disease activity and improve the nutritional status of patients with after IPAA. Trial registration ChiCTR, ChiCTR1900022243. Registered 31 March 2019, https://www.chictr.org.cn/historyversionpub.aspx?regno=ChiCTR1900022243

The objective of this study was to evaluate and collect current evidence on the effect of probiotics in preventing pouchitis after restorative ileal pouch anal anastomosis (IPAA). The Pubmed, Medline, EMbase, CINAHL, Web of Science, and Scopus bibliographic, and Google Scholar databases were searched between 1966 and May 2007, and relevant controlled clinical trials were extracted, reviewed, and validated according to the study protocol. The outcome of interest was for pouchitis defined by a pouchitis disease activity index (PDAI) ≥7. Five randomized, placebo-controlled clinical trials were included in the meta-analysis. Pooling of the results from these trials yielded an odds ratio (OR) of 0.04 with a 95% CI of 0.01–0.14 ( P  < 0.0001) in the treatment group in comparison with the placebo group. In conclusion, the benefit of probiotics in the management of pouchitis after IPAA operation was confirmed by the meta-analysis.

Background Almost 15% of patients with ulcerative colitis (UC) will require a proctocolectomy with ileal pouch–anal anastomosis (IPAA) as a result of fulminant colitis, dysplasia, cancer, or medical refractory diseases. Around 50% will experience pouchitis, an idiopathic inflammatory condition involving the ileal reservoir, responsible for digestive symptoms, deterioration in quality of life, and disability. Though the majority of initial cases of pouchitis are easily managed with a short course of antibiotics, in about 10% of cases, inflammation of the pouch becomes chronic with very few treatments available. Previous studies have suggested that manipulating the composition of intestinal flora through antibiotics, probiotics, and prebiotics achieved significant results for treating acute episodes of UC-associated pouchitis. However, there is currently no established effective treatment for chronic antibiotic-dependent pouchitis. Fecal microbiota transplantation (FMT) is a novel therapy involving the transfer of normal intestinal flora from a healthy donor to a patient with a medical condition potentially caused by the disrupted homeostasis of intestinal microbiota or dysbiosis. Methods Our project aims to compare the delay of relapse of chronic recurrent pouchitis after FMT versus sham transplantation. Forty-two patients with active recurrent pouchitis after having undergone an IPAA for UC will be enrolled at 12 French centers. The patients who respond to antibiotherapy will be randomized at a ratio of 1:1 to receive either FMT or sham transplantation. Discussion On April 30, 2014, the World Health Organization published an alarming report on antibiotic resistance. Finding an alternative medical treatment to antibiotics in order to prevent relapses of pouchitis is therefore becoming increasingly important given the risk posed by multiresistant bacteria. Moreover, if the results of this study are conclusive, FMT, which is less expensive than biologics, could become a routine treatment in the future. Trial registration ClinicalTrials.gov, NCT03524352 . Registered on 14 May 2018.

Pouchitis, defined as inflammation of the ileal pouch, is the most common complication following restorative proctocolectomy for refractory ulcerative colitis. Antibiotics remain the first line of therapy for pouchitis, but the majority of patients develop subsequent episodes and some are refractory to antibiotic therapy. This highlights the need for more effective treatment options and points to a more complex pathophysiology beyond the role of th pouch microbiome, similar to what is seen in inflammatory bowel disease. In this review, we outline the putative mechanisms of pouchitis, including genetic predisposition, microbiome alterations, dysfunction of the intestinal barrier and the immune system and review the available animal models of pouchitis. In addition, we introduce the concept of pouchitis as a possible transmural disease and discuss the potential role of non-immune cells, including stromal cells, in perpetuating inflammation and intestinal barrier dysfunction. We discuss future directions, implications for novel therapies and propose novel multicellular disease models that can better capture the complexity of pouchitis pathogenesis.

Total abdominal proctocolectomy with ileal pouch–anal anastomosis (IPAA) for ulcerative colitis (UC) is associated with substantial complications despite the benefits of managing refractory and/or neoplasia-associated disease. For the purpose of this review, we focused on the diagnosis of some of the most common inflammatory and structural pouch disorders and their respective management. Pouchitis is the most common complication, and it is typically responsive to antibiotics. However, chronic antibiotic refractory pouchitis (CARP) has been increasingly recognized, and biologic therapies have emerged as the mainstay of therapy. Crohn's-like disease of the pouch (CLDP) can affect up to 10% of patients with UC after IPAA. Medical options are similar to CARP therapies, including biologics with immunomodulators. Studies have shown higher efficacy rates of biologics for CLDP when compared with those for CARP. In addition, managing stricturing and fistulizing CLDP is challenging and often requires interventional endoscopy (balloon dilation and/or stricturotomy) and/or surgery. The implementation of standardized diagnostic criteria for inflammatory pouch disorders will help in advancing future therapeutic options. Structural pouch disorders are commonly related to surgical complications after IPAA. We focused on the diagnosis and management of anastomotic leaks, strictures, and floppy pouch complex. Anastomotic leaks and anastomotic strictures occur in approximately 15% and 11% of patients with UC after IPAA, respectively. Further complications from pouch leaks include the development of sinuses, fistulas, and pouch sepsis requiring excision. Novel endoscopic interventions and less invasive surgical procedures have emerged as options for the management of these disorders.

Abstract Background Pouchitis is the most common complication of restorative proctocolectomy (RPC) with ileal pouch-anal anastomosis (IPAA) in patients with ulcerative colitis (UC). We previously reported the presence of anti-integrin αvβ6 antibodies in the serum of patients with UC. This study investigated the association between anti-integrin αvβ6 antibodies and the development of pouchitis in patients with UC. Methods Serum levels of anti-integrin αvβ6 antibodies were measured by enzyme-linked immunosorbent assay in 16 patients with UC who underwent RPC with IPAA. Integrin αvβ6 expression in the colonic, terminal ileal, and pouch epithelium was examined using immunohistochemistry and western blot analysis. Results Anti-integrin αvβ6 antibody levels in patients with UC were significantly decreased at 3, 9, and 12 months after RPC (P < .05). However, in patients who developed pouchitis, antibody levels remained high. The antibody levels at the time of RPC were significantly higher in patients who developed pouchitis compared to those who did not. Kaplan-Meier analysis revealed a significantly higher incidence of pouchitis in patients with antibody levels above the cutoff at the time of RPC. Although integrin αvβ6 was not expressed in the terminal ileal epithelium at the time of RPC, expression became positive in the pouch epithelium of patients with pouchitis. Conclusions The anti-integrin αvβ6 antibody levels in patients with UC were decreased after RPC but remained high in patients who developed pouchitis. The antibody levels at the time of RPC may serve as a potential prognostic biomarker for predicting the risk of pouchitis in patients with UC. Lay Summary Anti-integrin αvβ6 antibody levels remained high in patients with ulcerative colitis who developed pouchitis after restorative proctocolectomy (RPC). The antibody level at the time of RPC could predict the onset of pouchitis in patients who underwent RPC.

A subset of patients who undergo total proctocolectomy with ileal pouch-anal anastomosis (IPAA) creation for ulcerative colitis (UC) will later develop Crohn's disease (CD) of the pouch, which has been associated with significant morbidity. We aimed to analyze the incidence of CD of the pouch and to review the existing diagnostic criteria utilized. A systematic search performed through March 1, 2018, identified 12 studies that reported the incidence of CD of the pouch after IPAA for UC or indeterminate colitis (IC). We compiled all diagnostic criteria utilized in these studies and then performed a meta-analysis using random effects modeling to estimate the overall incidence of CD of the pouch in this population. Among 4843 patients with an IPAA for UC or IC, 10.3% of patients were ultimately diagnosed with CD of the pouch (95% confidence interval [CI], 6.1%-15.4%). The most commonly reported diagnostic criteria were (1) presence of fistula/fistulae, (2) stricture involving the pouch or prepouch ileum, and (3) presence of prepouch ileitis. In a secondary analysis, excluding those studies that included patients with a preoperative diagnosis of IC, the incidence of CD of the pouch was 12.4% (95% CI, 9.0%-16.1%). The estimated incidence of 10.3% will assist gastroenterologists and surgeons in preoperative counseling regarding the potential to develop CD of the pouch. There is an unmet need for common diagnostic criteria for a more standardized approach to the diagnosis of CD of the pouch.