Randomized, Double-Blind, Placebo-Controlled Study of Anti-Mycobacterial Therapy (RHB-104) in Active Crohn's Disease.

This study, conducted between 4 October 2013, and 30 November 2018, tested the hypothesis that triple antimicrobial therapy, targeting Mycobacterium avium subspecies paratuberculosis (MAP), long considered a putative cause, would favorably affect Crohn's disease. A double-blind multicenter study of adults with active Crohn's disease, (i.e., Crohn's Disease Activity Index [CDAI] 220-450 plus C-reactive protein ≥ 1.0 mg/dL, fecal calprotectin (FCP) >162.9 µg/g stool, or recent endoscopic or radiographic confirmation of active disease) receiving concomitant standard-of-care Crohn's disease treatment (Clinicaltrials.gov: NCT01951326) were stratified by anti-tumor necrosis factor use and randomized (1:1) to anti-MAP RHB-104 (clarithromycin 95 mg, rifabutin 45 mg, and clofazimine 10 mg per capsule) (n = 166), resulting in clarithromycin 950 mg/day, rifabutin 450 mg/day, and clofazimine 100 mg/day, or placebo (n = 165) for up to 52 weeks. A greater proportion of RHB-104 versus placebo-treated patients met the primary endpoint-remission (i.e., CDAI < 150)-at week 26 (36.7% [61/166] vs. 22.4% [37/165], respectively; 95% CI for difference: 4.6, 24.0, p = 0.0048; chi-square test). Clinical response (reduction of CDAI by ≥100 points from baseline) at week 26 (first secondary endpoint) was also higher among the patients treated with RHB-104 (73/166 [44.0%]) compared with placebo (50/165 [30.3%]; 95% CI for difference: 3.4, 24.0, p = 0.0116), and it remained higher at week 52 among the patients treated with RHB-104 (59/166 [35.5%] vs. (35/165 [21.2%] for placebo; 95% CI for difference: 4.7, 23.9, p = 0.0042). A statistically significantly greater decline in FCP (another prospective efficacy endpoint) was also observed in RHB-104-treated patients, compared with placebo, at weeks 12, 26, and 52. The rates of serious adverse events were similar between groups (RHB-104: 18.7%; placebo: 18.8%). No patient died during the study. Antimicrobial therapy directed against MAP resulted in significantly greater improvement in clinical and laboratory (FCP) measures of active Crohn's disease.

THE ROLE OF INVASIVE AND NON-INVASIVE MEASUREMENTS OF HVPG IN DECISION MAKING IN PATIENTS WITH PORTAL HYPERTENSIONAND ESOPHAGEAL VARICES.

Many researchers and clinicians have taken the value of hepatic venous pressure gradient (HVPG) as an essential prognostic factor in subjects with chronic liver disorders. And HVPG alterations characterize a predictive value in subjects at the beginning of the disease (HVPG 6 - 10 mmHg) as well as in subjects in whom hemodynamically significant portal hypertension has developed (HVPG ≥ 10 mmHg). Our review aims to present the feasibility and applicability of HVPG in modern clinical practice in patients with liver cirrhosis, including invasive and non-invasive methods. HVPG measurement is a feasible method with a favorable safety profile. However, hemodynamically significant portal hypertension also might be determined using non-invasive options as elastography, magnetic resonance imaging, and indices derived from laboratory parameters, e.g., aspartate aminotransferase-to-platelet ratio, platelet count/spleen diameter ratio, or VITRO score. Hepatic vein catheterization with the evaluation of HVPG is the current gold standard for determining portal pressure; however, new non-invasive techniques are nowadays more frequently used.

A Review of Colorectal Cancer in Terms of Epidemiology, Risk Factors, Development, Symptoms and Diagnosis.

This review article contains a concise consideration of genetic and environmental risk factors for colorectal cancer. Known risk factors associated with colorectal cancer include familial and hereditary factors and lifestyle-related and ecological factors. Lifestyle factors are significant because of the potential for improving our understanding of the disease. Physical inactivity, obesity, smoking and alcohol consumption can also be addressed through therapeutic interventions. We also made efforts to systematize available literature and data on epidemiology, diagnosis, type and nature of symptoms and disease stages. Further study of colorectal cancer and progress made globally is crucial to inform future strategies in controlling the disease's burden through population-based preventative initiatives.

Association Between Mycotoxin Exposure and Dietary Habits in Colorectal Cancer Development Among a Polish Population: A Study Protocol.

Colorectal cancer (CRC) is one of the most common and lethal types of cancer worldwide. The developing of this disease includes many factors such as genetic, socioeconomic, environmental, and lifestyle factors, and nutrition habits. The aim of the study is the determination of zearalenone and its metabolite level in the biological samples of participants at risk of CRC, in relation to the nutrition data and information on the quality of life dependent on health. In the cohort clinical trial, 150 participants aged between 50 and 65 will be studied. The participants will be assigned into two groups depending on the colonoscopy result. Participants will be tested at dietary intake, quality of life, sleep time and quality, stress level as well as biochemical parameters of the blood. Moreover, in the biological samples, concentration of zearalenone and its metabolites (α-zearalenol and ß-zearalenol) as well as the characteristics of gastrointestinal bacterial will be determined, and the end of the trial for both groups and their results will be compared. Taking into account the possible effect of mycotoxins and nutrition habits on the development of cancer, the results obtained may allow the formulation of new nutritional recommendations and reduce the development and occurrence of CRC.

Therapeutic applicability of helminths in autoimmune diseases - literature overview.

This paper presents an overview of published studies conducted on helminths - parasites of the human gastrointestinal tract. Making use of their ability for immunomodulation may lead to the introduction of effective therapies for autoimmune diseases. This paper presents chronologically attempts to treat autoimmune diseases not only of the gastrointestinal tract, but also of the nervous and endocrine systems, which have been undertaken for decades. The overview of analysed reports demonstrates that as medical knowledge on the cells and mediators participating actively in inflammatory processes accumulates, clinical trials focus on ever more specific areas concerning the pathomechanisms of autoimmune diseases. The outcomes of clinical trials conducted both on animals and humans give reasons to assume that the modification of the human intestinal microflora may be the key to fighting against these diseases.