Specific Bacteria and Metabolites Associated With Response to Fecal Microbiota Transplantation in Patients With Ulcerative Colitis.

Background & Aims: Fecal microbiota transplantation (FMT) can induce remission in patients with ulcerative colitis (UC). In a randomized controlled trial of FMT in patients with active UC, we aimed to identify bacterial taxonomic and functional factors associated with response to therapy.

Methods: We performed a double-blind trial of 81 patients with active UC randomly assigned to groups that received an initial colonoscopic infusion and then intensive multidonor FMT or placebo enemas, 5 d/wk for 8 weeks.

Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma.

Background: Patients with diffuse large B-cell lymphoma that is refractory to primary and second-line therapies or that has relapsed after stem-cell transplantation have a poor prognosis. The chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel targets and eliminates CD19-expressing B cells and showed efficacy against B-cell lymphomas in a single-center, phase 2a study.

Methods: We conducted an international, phase 2, pivotal study of centrally manufactured tisagenlecleucel involving adult patients with relapsed or refractory diffuse large B-cell lymphoma who were ineligible for or had disease progression after autologous hematopoietic stem-cell transplantation.

The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL.

Duvelisib (also known as IPI-145) is an oral, dual inhibitor of phosphatidylinositol 3-kinase δ and γ (PI3K-δ,γ) being developed for treatment of hematologic malignancies. PI3K-δ,γ signaling can promote B-cell proliferation and survival in clonal B-cell malignancies, such as chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). In a phase 1 study, duvelisib showed clinically meaningful activity and acceptable safety in CLL/SLL patients.

Variants in ACTG2 underlie a substantial number of Australasian patients with primary chronic intestinal pseudo-obstruction.

Background: Primary chronic intestinal pseudo-obstruction (CIPO) is a rare, potentially life-threatening disorder characterized by severely impaired gastrointestinal motility. The objective of this study was to examine the contribution of ACTG2, LMOD1, MYH11, and MYLK mutations in an Australasian cohort of patients with a diagnosis of primary CIPO associated with visceral myopathy.

Methods: Pediatric and adult patients with primary CIPO and suspected visceral myopathy were recruited from across Australia and New Zealand.

Urbanization and the gut microbiota in health and inflammatory bowel disease.

In the 21st century, urbanization represents a major demographic shift in developed and developing countries. Rapid urbanization in the developing world has been associated with an increasing incidence of several autoimmune diseases, including IBD. Patients with IBD exhibit a decrease in the diversity and richness of the gut microbiota, while urbanization attenuates the gut microbial diversity and might have a role in the pathogenesis of IBD.

Identification of Endpoints for Development of Antifibrosis Drugs for Treatment of Crohn's Disease.

Background & Aims: Intestinal fibrosis is a challenge to management of patients with Crohn's disease (CD); there is an urgent need to expedite development of antifibrosis drugs for this disease. The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) aimed to identify a set of endpoints that can be used to determine efficacy of antifibrosis agents tested in clinical trials of patients with CD.

Methods: We conducted a systematic review to identify clinical, radiologic, biochemical, endoscopic, and composite endpoints used in assessing activity of fibrostenosing CD and response to treatment, and determined their operational properties.

Anti-TNF Therapeutic Drug Monitoring in Postoperative Crohn's Disease.

Background: Anti-TNF prevents postoperative Crohn's disease recurrence in most patients but not all. This study aimed to define the relationship between adalimumab pharmacokinetics, maintenance of remission and recurrence.

Methods: As part of a study of postoperative Crohn's disease management, some patients undergoing resection received prophylactic postoperative adalimumab.

Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial.

Background: The intestinal microbiota is implicated in the pathogenesis of ulcerative colitis. Faecal microbiota transplantation is a novel form of therapeutic microbial manipulation, but its efficacy in ulcerative colitis is uncertain. We aimed to establish the efficacy of intensive-dosing, multidonor, faecal microbiota transplantation in active ulcerative colitis.

Microbial Factors Associated with Postoperative Crohn's Disease Recurrence.

Background And Aims: The intestinal microbiota is a key antigenic driver in Crohn's disease [CD]. We aimed to identify changes in the gut microbiome associated with, and predictive of, disease recurrence and remission.

Methods: A total of 141 mucosal biopsy samples from 34 CD patients were obtained at surgical resection and at colonoscopy 6 and/or 18 months postoperatively; 28 control samples were obtained: 12 from healthy patients [healthy controls] and 16 from hemicolectomy patients [surgical controls].

Individualised mindfulness-based stress reduction for head and neck cancer patients undergoing radiotherapy of curative intent: a descriptive pilot study.

People with head and neck cancer (HNC) experience elevated symptom toxicity and co-morbidity as a result of treatment, which is associated with poorer psychosocial and quality-of-life (QoL) outcomes. This Phase I study examined whether an individualised mindfulness-based stress reduction (IMBSR) programme could be successfully used with HNC patients undergoing curative treatment. Primary aims were to explore feasibility, compliance, acceptability and fidelity.

Comparison of Fecal Inflammatory Markers in Crohn's Disease.

Background: Fecal biomarkers are used increasingly to monitor Crohn's disease (CD). However, the relative accuracy of different markers in identifying inflammation has been poorly evaluated. We evaluated fecal calprotectin (FC), lactoferrin (FL), and S100A12 (FS) using endoscopic validation in a prospective study of the progression of CD after intestinal resection.

Early Course of Inflammatory Bowel Disease in a Population-Based Inception Cohort Study From 8 Countries in Asia and Australia.

Background & Aims: The incidence of inflammatory bowel disease (IBD) is increasing in Asia, but little is known about disease progression in this region. The Asia-Pacific Crohn's and Colitis Epidemiology Study was initiated in 2011, enrolling subjects from 8 countries in Asia (China, Hong Kong, Indonesia, Sri Lanka, Macau, Malaysia, Singapore, and Thailand) and Australia. We present data from this ongoing study.

Efficacy of thiopurines and adalimumab in preventing Crohn's disease recurrence in high-risk patients - a POCER study analysis.

Background: Crohn's disease recurs in the majority of patients after intestinal resection.

Aim: To compare the relative efficacy of thiopurines and anti-TNF therapy in patients at high risk of disease recurrence.

Methods: As part of a larger study comparing post-operative management strategies, patients at high risk of recurrence (smoker, perforating disease, ≥2nd operation) were treated after resection of all macroscopic disease with 3 months metronidazole together with either azathioprine 2 mg/kg/day or mercaptopurine 1.

The Association of Estimated Glomerular Filtration Rate With Diabetic Retinopathy and Macular Edema.

Purpose: Albuminuria, a marker of diabetic kidney disease, is closely associated with diabetic retinopathy (DR) and diabetic macular edema (DME). However, the relationship between estimated glomerular filtration rate (eGFR) with DR and DME remains unclear, particularly in type 2 diabetes. We investigated the association of eGFR with DR and DME in a sample of patients with type 2 diabetes.

Impact of drug therapy and surgery on quality of life in Crohn's disease: a systematic review.

Crohn's disease is associated with substantially impaired health-related quality of life (HRQoL). Even in the absence of active disease, patients with Crohn's disease report lower HRQoL, poorer function, and greater concerns, than those without disease. Achievement of disease remission in Crohn's disease, whether by pharmacological or surgical means, is associated with improved HRQoL, although the durability of the improvement seen after intestinal resection is uncertain because of the high rate of postoperative disease recurrence.

Effect of intestinal resection on quality of life in Crohn's disease.

Introduction: Patients with Crohn's disease have poorer health-related quality of life [HRQoL] than healthy individuals, even when in remission. Although HRQoL improves in patients who achieve drug-induced or surgically induced remission, the effects of surgery overall have not been well characterised.

Methods: In a randomised trial, patients undergoing intestinal resection of all macroscopically diseased bowel were treated with postoperative drug therapy to prevent disease recurrence.

Right Precordial T-Wave Inversion in Healthy Endurance Athletes Can Be Explained by Lateral Displacement of the Cardiac Apex.

Objectives: The objective of this study was to test the hypothesis that T-wave inversion in the right precordial leads (TWI) reflects lateral displacement of the heart such that the surface electrocardiographic (ECG) leads overlie a greater proportion of the right ventricle (RV).

Background: TWI on ECG is more frequently observed among endurance athletes (EAs) than in the general population, the underlying mechanism for which is unclear.

Methods: Sixty-eight EAs and 41 nonathletic control subjects underwent ECG and cardiac magnetic resonance imaging (CMRI).

Understanding the experiences of Mandarin-speaking patients diagnosed with life-threatening cancer in Australia.

Objective: People from ethnic minority groups who receive cancer care outside their country of origin may experience poor survival and psychological outcomes relative to that nation's majority groups. This exploratory qualitative study aimed to understand the experience of a large minority group of Mandarin-speaking cancer patients (MSCPs) after diagnosis and treatment of their cancer in Australia, with a view to delineate if cultural or linguistic factors affected the quality of care provided.

Method: We employed an exploratory qualitative design involving interviews with 22 MSCPs who were treated during 2009 at the Peter MacCallum Cancer Centre (PMCC) in Melbourne, Australia.

Islet cell transplantation in Australia: screening, remote transplantation, and incretin hormone secretion in insulin independent patients.

Islet cell transplantation has emerged as a treatment modality for type 1 diabetes in the last 15 years due to the Edmonton protocol leading to consistent and sustained exogenous insulin independence post-transplantation. In recent years, consortia that involve both local and remote islet cell centers have been established, with local centers responsible for processing and shipping of islet cells, and remote centers only transplanting them. There are, however, few data on patient outcomes at remote centers.

Mesalamine did not prevent recurrent diverticulitis in phase 3 controlled trials.

Background & Aims: No therapy has been proven to prevent the recurrence of diverticulitis. Mesalamine has shown efficacy in preventing relapse in inflammatory bowel disease, and there is preliminary evidence that it might be effective for diverticular disease. We investigated the efficacy of mesalamine in preventing recurrence of diverticulitis in 2 identical but separate phase 3, randomized, double-blind, placebo-controlled, multicenter trials (identical confirmatory trials were conducted for regulatory reasons).