The gut microbiome has been shown to influence the response of tumors to anti–PD-1 (programmed cell death–1) immunotherapy in preclinical mouse models and observational patient cohorts. However, modulation of gut microbiota in cancer patients has not been investigated in clinical trials. In this study, we performed a phase 1 clinical trial to assess the safety and feasibility of fecal microbiota transplantation (FMT) and reinduction of anti–PD-1 immunotherapy in 10 patients with anti–PD-1–refractory metastatic melanoma. We observed clinical responses in three patients, including two partial responses and one complete response. Notably, treatment with FMT was associated with favorable changes in immune cell infiltrates and gene expression profiles in both the gut lamina propria and the tumor microenvironment. These early findings have implications for modulating the gut microbiota in cancer treatment.

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Queries are meant to draw your attention to edits, inconsistencies or issues that are unclear. If we just ask you to confirm edits are correct, a simple yes/ok between the brackets will do [Au: OK? Is this what you meant? Edits OK? yes]. If questions are asked, please rephrase/update the manuscript text when addressing queries, so that the message is conveyed to the reader (do NOT just type your answer to our query).] [Au: Throughout the manuscript, please use consistent terminology. For example, acute diverticulitis is diverticular disease and in several instances, they are mentioned separately. For clearer understanding, please use consistent terminology and define cleary what diverticular disease refers to. Similarly, there is a slight ambiguity between the terms diverticulosis and asymptomatic diverticulosis. My understanding is that diverticulosis is always asymptomatic. Please refer to them consistently if they are used to refer to the same condition. Is acute uncomplicated diverticulitis as in some instances, its refered to as uncomplicated acute diverticulitis? Please also use the abbreviation, AUD, if this terminology is widely accepted in the field. Just wanted to flag these here to make it easier for you to address.][Au: Important! As I am managing the references for this manuscript, it is essential that changes to references are noted to me in a comment rather than edited manually (as this will likely unlink the references and cause much confusion). If a reference needs to be added, include the full reference details (at a minimum, PMID or DOI are needed) and precise location to be cited. If a reference needs to be deleted, state which reference (author, year) and not just the reference number (as this will change with every change to the references).You can move text around, including the references associated with any given statement, but please don't edit the reference list at the end of the document.

In an average-risk screening population, technically adequate capsule colonoscopy identified individuals with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity and 82% specificity. Capsule performance seems adequate for patients who cannot undergo colonoscopy or who had incomplete colonoscopies. Additional studies are needed to improve capsule detection of serrated lesions. Clinicaltrials.gov number: NCT01372878.

BACKGROUND & AIMS: This study compared pharmacokinetics, symptomatic and endoscopic efficacy, safety, and immunogenicity of a subcutaneous formulation of the infliximab biosimilar CT-P13 (CT-P13 SC) vs intravenous CT-P13 (CT-P13 IV) in patients with inflammatory bowel disease (IBD). METHODS: This randomized, multicenter, open-label, parallel-group, phase 1 study enrolled tumor necrosis factor inhibitor-naïve patients with active ulcerative colitis (total Mayo score 6-12 points with endoscopic subscore 2) or Crohn's disease (Crohn's Disease Activity Index 220-450 points) at 50 centers. After CT-P13 IV induction at Week (W) 0/ W2, patients were randomized (1:1) to receive CT-P13 SC every 2 weeks (q2w) from W6 to W54 or CT-P13 IV every 8 weeks from W6 to W22. At W30, all patients receiving CT-P13 IV switched to CT-P13 SC q2w until W54. The primary endpoint was noninferiority of CT-P13 SC to CT-P13 IV for observed predose CT-P13 concentration at W22 (C trough,W22 ), concluded if the lower bound of the 2-sided 90% confidence interval (CI) for the ratio of geometric least-squares means exceeded 80%. RESULTS: Overall, 66 and 65 patients were randomized to CT-P13 SC and CT-P13 IV, respectively. The primary endpoint of noninferiority was met with a geometric least-squares means ratio for C trough,W22 of 1154.17% (90% CI 786.37-1694.00; n ¼ 59 [CT-P13 SC]; n ¼ 57 [CT-P13 IV]). W30/W54 clinical remission rates were comparable between arms. Other efficacy,

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SB inflammation is detected in the majority of CD patients in clinical and biomarker remission. SBMH and DR were rare and were independent of treatment modality. Our findings represent the true inflammatory burden in quiescent patients with SBCD.

Early colonoscopy in acute diverticulitis is feasible and safe in the absence of pericolic air on CT, and has greater compliance. However, no added value is apparent compared with the CT scan currently used.