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BACKGROUND AND AIM PBK-1701TC is a novel sulfate tablet-based that contains 320 mg of simethicone and delivers 90% of the salt and water delivered by oral sulfate solution (OSS) preparation. This study evaluated the efficacy, safety, and tolerability of PBK-1701TC compared with OSS in bowel preparation for colonoscopy. METHODS This randomized, multicenter, phase 3 non-inferiority trial included adults aged 19 years or older with a body mass index of 19-30 kg/m2 undergoing colonoscopy at five university hospitals in Korea. The primary efficacy endpoint was successful bowel-cleansing rate, defined as Harefield Cleansing Scale grade A or B as evaluated by blinded central readers. Secondary endpoints included the presence of residual air bubbles. Adverse events and laboratory evaluations were monitored to assess safety. Tolerability was assessed via participant interview. RESULTS Overall, 235 participants were randomized, and 224 were included in the per-protocol analysis (PBK, 112; OSS, 112). Successful bowel cleansing was achieved for 95.5% (107/112) in the PBK group, which was non-inferior to the OSS group (98.2%, 110/112) with a difference of -2.7% (one sided 97.5% confidence limit, -8.1%). The participants in the PBK group had fewer intraluminal bubbles (0.9% vs 81.3%, P

A biosimilar of infliximab, CT-P13 (Remsima®) has the potential to reduce treatment costs and enhance access to biological therapy for inflammatory bowel disease (IBD) patients. However, long-term clinical data on its use for IBD treatment are currently sparse. We aimed to investigate the long-term efficacy and safety of CT-P13 therapy in a large, real-life IBD cohort.A total of 368 IBD patients (227 with Crohn's disease [CD] and 141 with ulcerative colitis [UC]) treated with CT-P13 at 16 referral hospitals in Korea between July 2012 and December 2017 were retrospectively analyzed.The cumulative retention rates at years 1, 3, and 5 were 86.1%, 68.5%, and 58.7% and 69.7%, 46.0%, and 26.7% in anti-tumor necrosis factor (TNF)-naïve CD and UC patients, respectively. The clinical response and remission rates at week 14 and at years 1, 3, and 5 were 94.3%, 92.7%, 76.8%, and 17.6% and 78.6%, 82.4%, 72.2%, and 17.6% in anti-TNF-naïve CD and 85.6%, 80.0%, 55.2%, and 6.7% and 42.6%, 59.8%, 44.2%, and 6.7% in anti-TNF-naïve UC patients, respectively. Among patients who switched from the biologic originator to CT-P13, the cumulative retention rates at years 1, 3, and 5 were 88.5%, 66.1%, and 44.8% in CD, and 73.9%, 42.5%, and 42.5% in UC patients, respectively. Significant improvements in disease activity scores were accompanied by marked reductions in inflammatory marker levels, and no unexpected adverse events including death or malignancy occurred during the study period.Long-term treatment with CT-P13 is effective in inducing and maintaining disease improvement and is well-tolerated in patients with IBD. CT-P13 may be a promising treatment option for IBD.

Background and Aim There is controversy about the surveillance interval after colonoscopy when 5–10 adenomas have been found on index colonoscopy. This study aimed to investigate the risk of colorectal neoplasm (CRN) according to the number of adenomas at index colonoscopy. Methods A retrospective, multicenter study was conducted at 10 university hospitals in Korea. We included 1394 patients with ≥ 3 adenomas at index colonoscopy. The risk of advanced CRN was compared according to the number of adenomas (intermediate risk group, 3–4 small adenomas or at least one ≥ 10 mm, and high risk group, ≥ 5 small adenomas or ≥ 3 at least one ≥ 10 mm). Results Overall, 164 (11.8%) developed an advanced CRN after a mean of 4.0 years from baseline colonoscopy. The 3-year and 5-year risk of advanced CRN was 2.1% (95% CI 2.09–2.11) and 14.4% (95% CI 14.36–14.44) in intermediate risk group and 3.2% (95% CI 3.19–3.21) and 23.3% (95% CI 19.15–19.25) in high risk group (P = 0.01). Having ≥ 5 adenomas (OR = 1.57, 95% CI 1.11–2.23, P = 0.01) detected at index colonoscopy was a significant risk factor for developing advanced CRN. Conclusions Although risk of advanced CRN in patients with 5–10 adenomas was significantly higher than that in patients with 3–4 adenomas, the cumulative risk at 3 years was low at 3.2%. Thus, we suggest that a 3-year surveillance interval might be appropriate for the patients with 5–10 adenomas, and further prospective studies are needed to investigate whether more intensive surveillance is needed in this group.

Background Although statin use has been reported to reduce the risk of colorectal cancer beyond its cholesterol-lowering effects, the benefit of statins against colorectal adenoma has not been fully clarified. We aimed to investigate the association between statin use and the risk of colorectal adenoma. Methods We conducted a systematic literature search on MEDLINE, EMBASE, and the Cochrane Library using the primary keywords “adenoma,” “polyp,” “colorectal,” “colon,” “rectal,” “rectum,” “neoplasia,” “neoplasm,” “statin,” “3-hydroxy-3-methylglutaryl-coenzyme A,” and “HMG-CoA.” Studies were included if they evaluated the association between statin use and adenoma and reported relative risks (RRs) or odds ratios or provided data for estimation. Pooled estimates were calculated using the random-effects model. Results Six studies including 13 239 patients were analyzed. The median proportion of patients with any adenoma was 29.7% (range, 20.9–38.4%) in patients taking statins and 31.2% (range, 19.6–63.4%) in patients not taking statins across included studies. The median proportion of patients with advanced adenoma in those taking statins was 7.7% (range, 3.1–27.2%), whereas that in patients not taking statins was 11.3% (range, 3.5–32.4%). On meta-analysis, statin use did not significantly affect the risk of any adenoma (pooled RR = 0.901; 95% confidence interval [CI], 0.735–1.104); however, it was associated with a lower risk of advanced adenoma (pooled RR = 0.833; 95% CI, 0.750–0.925). Conclusions Statin use seems to be associated with a reduced risk of advanced adenoma, but not any adenoma. Statins may prevent neoplastic progression of adenomas rather than the development of adenomas.

Background and Aim: Advanced adenoma (> 10 mm in diameter, villous structure, or high-grade dysplasia) in young patients may have different characteristics and prognosis compared with those in older patients. We aimed to compare the incidence of colorectal neoplasms in young patients with older patients after removing high-risk adenoma (advance adenoma or ≥ 3 adenomas). Methods: A retrospective, multicenter study was conducted at 13 university hospitals in Korea. The 1479 patients who removed high-risk adenoma at index colonoscopy and followed by surveillance colonoscopy ≥ 2.5 years after were included. The cumulative incidence of overall and advanced colorectal neoplasms was compared according to the age groups (group 1

Background Despite recent advances in studies on the gastric microbiome, the role of the non‐Helicobacter pylori gastric microbiome in gastric carcinogenesis remains unclear. We evaluated the characteristics of the gastric microbiome and metagenomic functions in patients with IM. Methods Participants were classified into six groups according to disease status (chronic superficial gastritis [CSG], intestinal metaplasia [IM], and cancer) and H. pylori‐ infection status (H. pylori‐positive and H. pylori‐negative). The gastric microbiome was analyzed in mucosal tissues at the gastric antrum by 16S rRNA gene sequencing. Moreover, we assessed the metagenome including the type IV secretion system (T4SS) gene, as T4SS proteins are essential for transferring CagA from H. pylori- into the human gastric epithelium. Results Among the 138 included patients, 48, 9, 23, 14, 12, and 32 were classified into the H. pylori‐negative CSG, H. pylori‐negative IM, H. pylori‐negative cancer, H. pylori‐positive CSG, H. pylori‐positive IM, and H. pylori‐positive cancer groups, respectively. Cyanobacteria were predominant in the H. pylori‐negative CSG group compared to in the H. pylori‐negative IM and H. pylori‐negative cancer groups (H. pylori‐negative CSG vs H. pylori‐negative IM vs H. pylori‐negative cancer: 14.0% vs 4.2% vs 0.04%, P

This study was conducted to evaluate the relevance of the soluble form of c-Met protein, a truncated form of the c-Met membrane receptor involved in the CagA pathway, as a potential biomarker for gastric cancer. Among 290 gastric cancer case-control sets selected from the Korean Multicenter Cancer Cohort, the plasma concentrations of soluble c-Met protein were measured with enzyme-linked immunosorbent assays. Using analysis of variance and covariance models with age, sex, smoking, Helicobacter pylori infection, and CagA seropositivity, the mean concentrations of soluble c-Met protein between cases and controls were compared. To evaluate the association between gastric cancer and a c-Met protein level, odds ratios and 95% confidence intervals were estimated using conditional logistic regression models. Interactions between CagA-related genes and the soluble c-Met protein concentration were also investigated. The overall median plasma concentration of soluble c-Met among cases was significantly lower than those of controls (1.390 vs. 1.610 ng/mL, p < 0.0001). Closer to the onset of gastric cancer, the soluble c-Met protein level decreased linearly in a time-dependent manner (p for trend = 0.0002). The combined effects between the CagA-related genes and the soluble c-Met protein concentration significantly intensified risks for gastric cancer. Restricted analyses including cases that had been diagnosed within 1 year after entering the cohort had a fair degree of ability (area under the receiver operating characteristic curve of 0.73-0.77) to discriminate gastric cancer cases from normal controls. Our findings demonstrate the potential of the soluble form of c-Met protein as a novel biomarker for gastric cancer. The beneficial effects of a high soluble c-Met concentration in human plasma are strongly supported.

The exact effect of probiotics on epithelial barrier function is not well understood. The aims of this study were to evaluate cytokine-induced epithelial barrier dysfunction in intestinal epithelial cells (IECs) and to study the role of probiotics in the prevention of epithelial barrier dysfunction. Caco-2 cells grown on transwell chambers were stimulated with tumor necrosis factor (TNF)-α or interferon (IFN)-γ basolaterally. Probiotic, Lactobacillus casei, was added 1 h before cytokine stimulation. MAPK inhibitors were added 15 min before L. casei stimulation. The electrical resistance and paracellular permeability of Caco-2 monolayers were measured. Distribution of zonula occludens (ZO)-1 protein was assessed by immunofluorescence, and Western blot analyses for ZO-1, p-Akt, and toll-like receptor (TLR) 2 were performed. Both TNF-α and IFN-γ stimulation on Caco-2 cells decreased transepithelial resistance (TER), increased epithelial permeability, and decreased ZO-1 expression of Caco-2 cells. In contrast, pretreatment of L. casei reversed the cytokine-induced dysfunction of TER, epithelial permeability, and ZO-1 expression. Reversal of cytokine-induced dysfunction of TER and intestinal permeability by L. casei was abrogated with MAPK inhibitor treatment. Lactobacillus casei stimulation on Caco-2 cells increased TLR2 and p-Akt expression. Probiotic, L. casei, prevents cytokine-induced epithelial barrier dysfunctions in IECs.

Background and study aims: A prepackaged low residue one-day diet (breakfast, lunch and dinner) has been recently developed to improve patient tolerance for bowel preparation prior to colonoscopy. The aims of this study were to evaluate the efficacy and tolerability of bowel preparation protocols based on a low residue diet and 4L polyethylene glycol (PEG) solution, and to compare these new options with the traditional liquid diet and the PEG 4L lavage. Methods: A total of 214 patients (mean age: 54.1 years; 120 male, 94 female) from four university hospitals were included in the analysis. Patients were randomized to receive a clear liquid diet and the PEG 4L regimen (106 patients) or the low residue test meals and the PEG 4L regimen (TM-PEG 4L, 108 patients). The colon cleansing efficacy of the different preparations was rated using the Ottawa bowel preparation scale. Results: No significant differences were observed between the treatment groups according to the Ottawa cleansing scale findings (PEG 4L: 2.97 vs TM-PEG 4L: 2.46, P = 0.063). The overall tolerability was higher in the TM-PEG 4L group than in the PEG 4L group (P = 0.036). No difference was found when the two groups were compared with regard to adverse events (P = 0.599). Conclusions: A prepackaged low residue one-day diet provided cleansing efficacy similar to that of a clear liquid diet and offered the benefit of improved tolerability compared to the conventional PEG 4L regimen.