Background:
Recent trials suggest fecal microbiota transplantation (FMT) with repeated enemas and high diversity FMT donors is a promising treatment to induce remission in ulcerative colitis (UC).
Methods:
We designed a prospective, open-label pilot study to assess the safety, clinical efficacy, and microbial engraftment of single FMT delivery by colonoscopy for active UC using a two donor fecal microbiota preparation (FMP). Safety and clinical endpoints of response, remission, and mucosal healing at week 4 were assessed. Fecal DNA and rectal biopsies were used to characterize the microbiome and mucosal CD4+ T cells, respectively, before and after FMT.
Results:
Seven patients (35%) achieved a clinical response by week 4. Three patients (15%) were in remission at week 4 and two of these patients (10%) achieved mucosal healing. Three patients (15%) required escalation of care. No serious adverse events were observed. Microbiome analysis revealed that restricted diversity of recipients pre-FMT was significantly increased by high diversity two donor FMP. The microbiome of recipients post-transplant was more similar to the donor FMP than the pre-transplant recipient sample in both responders and non-responders. Notably, donor composition correlated with clinical response. Mucosal CD4+ T cell analysis revealed a reduction in both Th1 and regulatory T cells post-FMT.
Conclusions:
High-diversity, two donor FMP delivery by colonoscopy is safe and effective in increasing fecal microbial diversity in patients with active UC. Donor composition correlated with clinical response and further characterization of immunological parameters may provide insight into factors influencing clinical outcome.
Based on a decision analytic Markov model, endoscopic non-cardia gastric cancer screening for high-risk races and ethnicities could be cost effective in the United States.
irrhosis is associated with extrahepatic hemorrhagic and thrombotic processes, such as gastrointestinal bleeding 1 and venous thromboembolism. 2-4 The cerebrovascular complications of cirrhosis are comparatively less well understood. Early studies 5,6 reported a reduced prevalence of stroke in patients with cirrhosis at the time of autopsy. More recent studies 7-9 similarly found a reduced risk of all stroke and ischemic stroke, but these studies had small and narrowly defined study cohorts. With regard to hemorrhagic stroke, a previous study 10 found that liver disease is associated with an increased risk of intracranial hemorrhage, but other studies 11,12 have not found this to be the case. Because of the continued uncertainty, we sought to assess the association between cir-rhosis and various stroke types in a large, nationally representative sample of Medicare beneficiaries. Methods Study Design We performed a retrospective cohort study of 1 618 059 Medicare beneficiaries using a 5% sample of inpatient and outpatient claims from January 1, 2008, through December 31, 2014. The Centers for Medicare & Medicaid Services provide health insurance to most US residents starting at 65 years of age. Beneficiaries' claims data from inpatient and outpatient encoun-IMPORTANCE Cirrhosis is associated with hemorrhagic and thrombotic extrahepatic complications. The risk of cerebrovascular complications is less well understood. OBJECTIVE To investigate the association between cirrhosis and various stroke types.
Background & Purpose
Liver disease is associated with both hemorrhagic and thrombotic processes, including an elevated risk of intracranial hemorrhage (ICH). We sought to assess the relationship between liver disease and outcomes after stroke, as measured by discharge disposition.
Methods
Using administrative claims data, we identified a cohort of patients hospitalized with stroke in California, Florida, and New York from 2005 to 2013. The predictor variable was liver disease. All diagnoses were defined using validated diagnosis codes. Ordinal logistic regression was used to analyze the association between liver disease and worsening discharge disposition: home, nursing/rehabilitation facility, or death. Secondarily, multiple logistic regression was used to analyze the association between liver disease and in-hospital mortality. Models were adjusted for demographics, vascular risk factors, and comorbidities.
Results
We identified 121,428 patients with ICH and 703,918 with ischemic stroke. Liver disease was documented in 13,584 patients (1.7%). Liver disease was associated with worse discharge disposition after both ICH (global odds ratio [OR], 1.28; 95% confidence interval [CI], 1.19–1.38) and ischemic stroke (OR, 1.23; 95% CI, 1.17–1.29). Similarly, liver disease was associated with in-hospital death after both ICH (OR, 1.33; 95% CI, 1.23–1.44) and ischemic stroke (OR, 1.60; 95% CI, 1.51–1.71).
Conclusions
Liver disease was associated with worse hospital discharge disposition and in-hospital mortality after stroke, suggesting worse functional outcomes.
BackgroundSystematic reviews with meta-analyses and meta-regression suggest that timely probiotic use can prevent Clostridium difficile infection (CDI) in hospitalized adults receiving antibiotics, but the cost effectiveness is unknown. We sought to evaluate the cost effectiveness of probiotic use for prevention of CDI versus no probiotic use in the United States.MethodsWe programmed a decision analytic model using published literature and national databases with a 1-year time horizon. The base case was modeled as a hypothetical cohort of hospitalized adults (mean age 68) receiving antibiotics with and without concurrent probiotic administration. Projected outcomes included quality-adjusted life-years (QALYs), costs (2013 US dollars), incremental cost-effectiveness ratios (ICERs; $/QALY), and cost per infection avoided. One-way, two-way, and probabilistic sensitivity analyses were conducted, and scenarios of different age cohorts were considered. The ICERs less than $100000 per QALY were considered cost effective.ResultsProbiotic use dominated (more effective and less costly) no probiotic use. Results were sensitive to probiotic efficacy (relative risk <0.73), the baseline risk of CDI (>1.6%), the risk of probiotic-associated bactermia/fungemia (<0.26%), probiotic cost (<$130), and age (>65). In probabilistic sensitivity analysis, at a willingness-to-pay threshold of $100000/QALY, probiotics were the optimal strategy in 69.4% of simulations.ConclusionsOur findings suggest that probiotic use may be a cost-effective strategy to prevent CDI in hospitalized adults receiving antibiotics age 65 or older or when the baseline risk of CDI exceeds 1.6%.
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