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Gasche C.,Medical University of Vienna | Ahmad T.,University of Exeter | Tulassay Z.,Semmelweis University | Baumgart D.C.,Humboldt University of Berlin | And 4 more authors.
Inflammatory Bowel Diseases | Year: 2015

Background: Iron deficiency anemia (IDA) is frequenly seen in inflammatory bowel disease. Traditionally, oral iron supplementation is linked to extensive gastrointestinal side effects and possible disease exacerbation. This multicenter phase-3 study tested the efficacy and safety of ferric maltol, a complex of ferric (Fe3+) iron with maltol (3-hydroxy-2-methyl-4-pyrone), as a novel oral iron therapy for IDA. Methods: Adult patients with quiescent or mild-to-moderate ulcerative colitis or Crohn's disease, mild-to-moderate IDA (9.5-12.0 g/dL and 9.5-13.0 g/dL in females and males, respectively), and documented failure on previous oral ferrous products received oral ferric maltol capsules (30 mg twice a day) or identical placebo for 12 weeks according to a randomized, double-blind, placebo-controlled study design. The primary efficacy endpoint was change in hemoglobin (Hb) from baseline to week 12. Safety and tolerability were assessed. Results: Of 329 patients screened, 128 received randomized therapy (64 ferric maltol-treated and 64 placebo-treated patients) and comprised the intent-to-treat efficacy analysis: 55 ferric maltol patients (86%) and 53 placebo patients (83%) completed the trial. Significant improvements in Hb were observed with ferric maltol versus placebo at weeks 4, 8, and 12: mean (SE) 1.04 (0.11) g/dL, 1.76 (0.15) g/dL, and 2.25 (0.19) g/dL, respectively (P < 0.0001 at all time-points; analysis of covariance). Hb was normalized in two-thirds of patients by week 12. The safety profile of ferric maltol was comparable with placebo, with no impact on inflammatory bowel disease severity. Conclusions: Ferric maltol provided rapid clinically meaningful improvements in Hb and showed a favorable safety profile, suggesting its possible use as an alternative to intravenous iron in IDA inflammatory bowel disease. Copyright © 2015 Crohn's & Colitis Foundation of America, Inc.


Evstatiev R.,Christian Doppler Laboratory | Alexeeva O.,Regional Clinical Hospital | Bokemeyer B.,Gastroenterology Practice | Chopey I.,National University | And 5 more authors.
Clinical Gastroenterology and Hepatology | Year: 2013

Background & Aims: Iron-deficiency anemia is the most common systemic complication of inflammatory bowel diseases (IBD). Iron-deficiency anemia recurs frequently and rapidly after iron-replacement therapy in patients with IBD. We performed a randomized, placebo-controlled trial to determine if administration of ferric carboxymaltose (FCM) prevents anemia in patients with IBD and low levels of serum ferritin. Methods: We performed a single-blind, multicenter study of nonanemic patients who had completed the FERGIcor study. Serum levels of ferritin were assessed every second month, and patients were given FCM (total iron dose, 1181 ± 662 mg; n = 105) or placebo (n = 99) when levels decreased to less than 100 μg/L. The primary end point was time to recurrence of anemia within 8 months. Secondary end points included changes of quality of life, disease activity, results from laboratory tests, and adverse events. Results: Anemia recurred in 26.7% of subjects given FCM and in 39.4% given placebo. The time to anemia recurrence was longer in the FCM group (hazard ratio, 0.62; 95% confidence interval, 0.38-1.00; P = .049). Markers of body levels of iron increased or remained at normal levels in subjects given FCM (ferritin increased by 30.3 μg/L, transferrin saturation increased by 0.6%) but decreased in the group given placebo (ferritin decreased by 36.1 μg/L, transferrin saturation decreased by 4.0%). Changes in quality of life and disease activity were comparable between groups. Adverse events were reported in 59.0% of the FCM group and 50.5% of the placebo group, and serious adverse events were reported in 6.7% and 8.1%, respectively. Conclusions: FCM prevents recurrence of anemia in patients with IBD, compared with placebo. Nevertheless, the high rate of anemia recurrence warrants optimization of the frequency and requirements for FCM treatment. Clinical Trial number: NCT00810004. © 2013 AGA Institute.


News Article | February 15, 2017
Site: www.prweb.com

March is colorectal cancer awareness month and, if you’re over 50 or if you’re younger than 50 but have a family history, it is a very good time to undergo a screening colonoscopy. Colorectal cancer is the second most common cancer in the United States and is also one of the most preventable. Most colorectal cancers develop from noncancerous polyps and removing these polyps can markedly reduce your risk of getting the disease. Ohio Gastroenterology & Liver Institute (http://www.ohiogi.com) cares about the community and strongly believes in the importance of colorectal screening. That is why OGI are donating 100 referrals to receive the HyGIeaCare® Prep which will allow patients to achieve excellent preparation of the colon by a method which is much more easily tolerated than traditional oral bowel preps. The HyGIeaCare® Center is located at 4746 Montgomery Rd. Suite 200 - Cincinnati, OH (call 513-569-1343 for scheduling) and features the HyGIeaCare® System which is approved by the U.S. Food and Drug Administration (FDA) and which effectively cleans the bowel using a gentle infusion of warm, gravity-flow filtered water. “At Ohio GI, we pride ourselves on personalized, professional, prompt, specialized care for each and every patient,” said Pradeep Bekal MD, a gastroenterologist from Ohio GI. “Screening for colorectal cancer saves lives and having an excellent preparation is key to effective colonoscopy. I urge the community to call and schedule their colonoscopy and benefit from our exclusive offering of HyGIeaCare® Prep.” The convenience of HyGIeaCare prep for colonoscopy At the HyGIeaCare® Center, the prep is performed in a clean and comfortable environment. Our trained technician leads the patient to a private room where he or she is seated on an ergonomic basin. The technician walks the patient through the procedure, which routinely takes less than one hour. A small, sterile, disposable nozzle is easily inserted about an inch into the rectum and a gentle stream of warm water flows into the bowel, loosening stool and causing the intestine to contract allowing for the comfortable, odorless and discreet evacuation of the colon. Water continues to gently flow until the technician determines the colon has been sufficiently cleansed. The HyGIeaCare Prep replaces traditional oral preps for colonoscopy and is performed immediately prior to the scheduled colonoscopy. It is safe, comfortable and preferred over oral preps. For more information about HyGIeaCare® please go to: http://www.hygieacare.com Ohio Gastroenterology and Liver Institute (“Ohio GI”) Ohio GI (http://www.ohiogi.com ) is the largest and most comprehensive private Gastroenterology practice servicing Greater Cincinnati, Fairfield and Northern Kentucky. Ohio GI combines unparalleled personalized expertise with prompt appointments in geographically convenient offices and related Endoscopy Centers. As the area’s Gastroenterology innovation leader Ohio GI introduces cutting edge therapies and medical technologies. Ohio GI offers consultative and procedural expertise by employing physicians who sub-specialize in important areas such as Inflammatory Bowel Disease (IBD), Pancreatic Diseases, Hepatology / Liver Diseases, Women’s Digestive Health and Esophageal / Swallowing Disorders as well as screening colonoscopy and preventative health management. Ohio GI monitors a variety of quality metrics (eg, cecal intubation rates, colonoscopy withdrawal times, adenoma detection rates) to ensure that its physicians exceed national benchmark standards. Ohio GI operates a major national Medical Research Center and has participated in many pivotal trials which have led to the approval of new treatments for Crohns Disease, Ulcerative Colitis, Irritable Bowel Syndrome, GERD, Hepatitis B, Hepatitis C, Duodenal Ulcers and Gastric Ulcers. The physicians of Ohio GI are also actively engaged in Greater Cincinnati’s local and regional medical community as well as with a variety of national Gastroenterology societies. About HyGIeaCare, Inc.(http://www.hygieacare.com) Chairman and CEO Gavriel (Gabi) Meron - the founder and former CEO of Given Imaging, the Company that successfully brought the PillCam to the world - partnered with Texas-based Lifestream Purification Systems to form HyGIeaCare, Inc. to bring the HyGIeaCare FDA-cleared Prep System and procedure exclusively to the GI world. The goal of HyGIeaCare is to provide unique services and solutions to gastroenterologists to deliver better GI outcomes for their patients and their practice through HyGIeaCare Centers to be established in the US and throughout the world.


Pox C.P.,Ruhr University Bochum | Altenhofen L.,Central Research Institute of Ambulatory Health Care in Germany | Brenner H.,German Cancer Research Center | Theilmeier A.,Gastroenterology Practice | And 2 more authors.
Gastroenterology | Year: 2012

Background & Aims: Screening colonoscopy examinations for colorectal cancer are offered in the United States and some European countries. Data on results and adverse effects of screening colonoscopy are limited. In autumn 2002, colonoscopy was introduced as part of a nationwide cancer screening program in Germany; it was offered to the general population for individuals 55 years of age or older. We collected and analyzed data from this program. Methods: We performed a prospective cross-sectional study, collecting results from 2,821,392 screening colonoscopies performed at more than 2100 practices by highly qualified endoscopists in Germany from January 2003 to December 2008. Data on participation, colorectal adenoma and cancer detection, and complications were collected using standardized documentation forms. The data generated were centrally processed and evaluated. Results: The cumulative participation rate was 17.2% of eligible women and 15.5% of eligible men 55-74 years old. The adenoma detection rate (ADR) was 19.4%, with a higher rate in men (25.8% vs 16.7% in women). Advanced adenomas were found in 6.4% of patients. Carcinomas were detected in 25,893 subjects (0.9%); most were of an early UICC stage (I, 47.3%; II, 22.3%; III, 20.7%; IV, 9.6%). The ADRs for gastroenterologists and nongastroenterologists were 25.1% and 22.3%, respectively (adjusted odds ratio, 1.18; 95% confidence interval, 1.16-1.21). The overall complication rate was 2.8/1000 colonoscopies, and the rate of serious complications was 0.58/1000 colonoscopies. Conclusions: A nationwide colonoscopy screening program that uses highly qualified endoscopists can detect a significant number of adenomas and early-stage carcinomas. The ADR for gastroenterologists was higher than for nongastroenterologists. © 2012 AGA Institute.


Raithel M.,Universitatsklinikum | Weidenhiller M.,Gastroenterology Practice | Hagel A.F.-K.,Universitatsklinikum | Hetterich U.,University Hospital | And 2 more authors.
Deutsches Arzteblatt International | Year: 2013

Background: Adverse food reactions (AFR) have has recently attracted increased attention from the media and are now more commonly reported by patients. Its classification, diagnostic evaluation, and treatment are complex and present a considerable challenge in clinical practice. Non-immune-mediated types of food intolerance have a cumulative prevalence of 30% to 40%, while true (immune-mediated) food allergies affect only 2% to 5% of the German population. Methods: We selectively searched the literature for pertinent publications on carbohydrate malabsorption, with special attention to published guidelines and position papers. Results: Carbohydrate intolerance can be the result of a rare, systemic metabolic defect (e.g., fructose intolerance, with a prevalence of 1 in 25 000 persons) or of gastrointestinal carbohydrate malabsorption. The malabsorption of simple carbohydrates is the most common type of non-immune-mediated food intolerance, affecting 20% to 30% of the European population. This condition is caused either by deficient digestion of lactose or by malabsorption of fructose and/or sorbitol. Half of all cases of gastrointestinal carbohydrate intolerance have nonspecific manifestations, with a differential diagnosis including irritable bowel syndrome, intolerance reactions, chronic infections, bacterial overgrowth, drug side effects, and other diseases. The diagnostic evaluation includes a nutritional history, an H2 breath test, ultrasonography, endoscopy, and stool culture. Conclusion: The goals of treatment for carbohydrate malabsorption are to eliminate the intake of the responsible carbohydrate substance or reduce it to a tolerable amount and to assure the physiological nutritional composition of the patient's diet. In parallel with these goals, the patient should receive extensive information about the condition, and any underlying disease should be adequately treated. © 2013, Deutscher Arzte-Verlag GmbH. All rights reserved.


Brenner H.,German Cancer Research Center | Hoffmeister M.,German Cancer Research Center | Birkner B.,Gastroenterology Practice | Birkner B.,Bavarian Association of Statutory Health Insurance Physicians | And 2 more authors.
American Journal of Gastroenterology | Year: 2014

OBJECTIVES: Randomized trials have shown that annual or biannual screening by guaiac-based fecal occult blood tests (gFOBTs) reduces colorectal cancer (CRC) mortality. Few clinical studies have evaluated diagnostic performance of gFOBT through validation by colonoscopy in all participants. We aimed for a comprehensive evaluation of diagnostic performance of gFOBT by age and sex under routine screening conditions. METHODS: Our analysis is based on 20,884 colonoscopies following up a positive gFOBT and 182,956 primary screening colonoscopies documented in a state-wide quality assurance program in Bavaria, Germany, in 2007-2009. Positive likelihood ratios (LR+), which represent an integrative measure of diagnostic performance, were derived, by age groups (55-59, 60-64, 65-69, 70-74 years) and sex, from a joint and comparative analysis of prevalences of colorectal neoplasms in both groups. RESULTS: Overall LR+ (95% confidence intervals) were 1.11 (1.06-1.15), 1.80 (1.72-1.88), and 5.04 (4.64-5.47) for non-advanced adenoma, advanced adenoma, and cancer, respectively. Assuming a specificity of gFOBT of 95.2%, as recently observed in a German study among 2,235 participants of screening colonoscopy, these LR+ would translate to sensitivities of 5.3%, 8.6%, and 24.2% for the three outcomes, respectively. Diagnostic performance was similarly poor among women and men and across age groups. CONCLUSIONS: The performance of gFOBT under routine screening conditions is even worse than previously estimated from clinical studies. In routine screening application, gFOBTs are expected to miss more than 9 out of 10 advanced adenomas and 3 out of 4 cancers. These results underline the need and the potential for better noninvasive CRC screening tests. © 2014 by the American College of Gastroenterology.


Baumgart D.C.,Charité - Medical University of Berlin | Bokemeyer B.,Gastroenterology Practice | Drabik A.,Biostatistics Consulting | Stallmach A.,University Hospital Jena | Schreiber S.,University of Kiel
Alimentary Pharmacology and Therapeutics | Year: 2016

Background Vedolizumab (VDZ) is a humanised monoclonal IgG1 antibody targeting α4β7 integrin. Aim To investigate the real-world efficacy of vedolizumab for the treatment of Crohn's disease (CD) and ulcerative colitis (UC). Methods A consecutive cohort of 212 adult IBD patients with active disease (HBI >7/partial Mayo >4) newly receiving VDZ was prospectively recruited from 7 academic and 17 community centres. The primary endpoint was clinical remission (CRM) (CD HBI ≤4, UC pMayo ≤1) in week 14. Secondary endpoints included steroid-free remission (SFCRM), clinical response (CRS) (HBI/pMayo score drop ≥3), vedolizumab impact on CRP, calprotectin and haemoglobin. Results Data of 97 CD (71.1% female, HBI 11) and 115 UC (42.6% female, pMayo 6) patients were analysed. Only 5.2% CD and 24.3% UC were anti-TNFα naïve. Most had extensive mucosal involvement (Montreal L3 69.1%/E3 53.9%). At week 14, 23.7% vs. 23.5% of CD vs. UC patients achieved CRM, 19.6% vs. 19.1% SFCRM and 60.8% vs. 57.4% CRS, respectively (all based on NRI). Week 14 CRM in CD was significantly associated with no history of extraintestinal manifestations (P = 0.019), no prior adalimumab use (P = 0.011), no hospitalisation in the past 12 months (P = 0.015) and low HBI score (P = 0.02) and in UC with active or previous smoking (P = 0.044/0.028) and no anti-TNFα (P = 0.023) use. Low HBI (P = 0.019) and no hospitalisation in the past 12 months (P = 0.01) predict CD CRM. The three most common AE were joint pain, acne and nasopharyngitis. Conclusion Vedolizumab is effective in routine use. © 2016 John Wiley & Sons Ltd.


Stock C.,German Cancer Research Center | Hoffmeister M.,German Cancer Research Center | Birkner B.,Gastroenterology Practice | Birkner B.,Bavarian Association of Statutory Health Insurance Physicians | Brenner H.,German Cancer Research Center
Endoscopy | Year: 2013

Background and study aims: After screening colonoscopy, additional colonoscopies may be required for adenoma surveillance or diagnostic reasons. The aim of the present study was to explore their utilization and findings in routine practice. Patients and methods: The study comprised an historical cohort of individuals participating in colonoscopy screening in 2006. Utilization and yield of neoplasms of additional colonoscopies performed in these individuals by the same physician (< 6 months and 6 - 36 months after screening) between 2006 and 2009 were assessed using data of a colonoscopy quality assurance program in Bavaria, Germany. Screening including polypectomy, and short-term follow-up colonoscopy was assumed to have been completed within ≤ 6 months. Multivariate logistic regression was used to identify predictors of additional colonoscopy and advanced neoplasms (high risk adenoma or colorectal cancer [CRC]) among those with additional colonoscopy during the period of 6 - 36 months after screening. Results: A total of 51 301 individuals undergoing screening colonoscopy were included. Of these, 10.1 % (95 % confidence interval [CI] 9.8 % - 10.3 %) had an additional colonoscopy performed by the same physician between 6 and 36 months after screening. The percentages of those with additional colonoscopy were 5.7 % (95 %CI 5.5 % - 5.9 %), 18.6 % (95 %CI 17.8 % - 19.4 %), and 33.7 % (95 %CI 32.2 % - 35.2 %) after negative screening, low risk adenoma at screening, and high risk adenoma at screening, respectively. The overall findings were negative colonoscopy, low risk adenoma, high risk adenoma, and CRC in 68.6 % (95 %CI 67.3 % - 69.8 %), 24.1 % (95 %CI 23.0 % - 25.3 %), 6.7 % (95 %CI 6.0 % - 7.4 %), and 0.6 % (95 %CI 0.4 % - 0.8 %), respectively. Younger age, male sex, screen-detected adenomas, inflammatory bowel disease, and early repeat colonoscopy within 6 months were predictors of additional colonoscopy. Older age, male sex, screen-detected adenomas, and surveillance indications were associated with increased risk of advanced neoplasms at post-screening colonoscopy. Conclusion: The results indicate frequent utilization of additional colonoscopies along with substantial adenoma yield in the first 3 years after screening colonoscopy. © Georg Thieme Verlag KG Stuttgart New York.


PubMed | Waldfriede Hospital, Gastroenterology Practice, Charité - Medical University of Berlin and University of Hamburg
Type: Journal Article | Journal: Gut and liver | Year: 2016

Standard treatments are not available for hilar nonresectable cholangiocarcinoma (NCC). It is unknown whether combination therapy of photodynamic therapy (PDT) plus systemic chemotherapy is superior to PDT alone.We retrospectively reviewed 68 patients with hilar NCC treated with either PDT plus chemotherapy (PTD-C) or PDT monotherapy (PDT-M). The primary endpoint was the mean overall survival rate. Secondary endpoints included the 1-year survival rate, risk of cholangitic complications, and outcomes, which were evaluated according to the chemotherapy protocol.More than 90% of the study population had advanced hilar NCC Bismuth type III or IV. In the PDT-M group (n=35), the mean survival time was 374 days compared with 520 days in the PDT-C group (n=33, p=0.021). The 1-year survival rate was significantly higher in the PDT-C group compared with the PDT-M group (88% vs 58%, p=0.001) with a significant reduction of mortality (hazard ratio, 0.20; 95% confidence interval, 0.07 to 0.58; p=0.003). Gemcitabine monotherapy resulted in a shorter survival time compared with the gemcitabine combination therapy (mean, 395 days vs 566 days; p=0.09). Cholangitic complications were observed at a similar frequency in the PDT-C and PDT-M groups.Combining repeated PDT with a gemcitabine-based combination therapy might offer a significant survival benefit in patients with hilar NCC.


PubMed | Gastroenterology Practice, AbbVie Deutschland GmbH & Co. KG and Lüneburg University
Type: | Journal: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association | Year: 2016

We performed a multicenter study to determine whether transabdominal bowel wall ultrasonography, a non-invasive procedure that does not require radiation, can be used to monitor progression of Crohns disease (CD).We performed a 12-month prospective, non-interventional study at 47 sites in Germany, from December 2010 through September 2014. Our study included 234 adult patients with CD who experienced a flare, defined as Harvey-Bradshaw index score of 7. All patients received treatment intensification-most with tumor necrosis factor antagonists. Ultrasound parameters and clinical data were assessed at baseline and then after 3, 6, and 12 months. The primary endpoint was the change in ultrasound parameters within 12 months of study enrollment.All patients included had bowel wall alterations either within the terminal ileum and/or segments of the colon. After 3 and 12 months, ultrasonographic examination showed significant improvements of nearly all ultrasound parameters, including reductions in bowel-wall thickening or stratification, decreased fibro-fatty proliferation, and increased signals in color Doppler ultrasound (P<.01 for all parameters at months 3 and 12). Median Harvey-Bradshaw index scores decreased from 10 at baseline to 2 after 12 months. Improvement in bowel-wall thickness correlated with reduced levels of c-reactive protein after 3 months (P.001).In a multicenter prospective study, we found that ultrasonographic examination can be used to monitor disease activity in patients with active CD. Bowel ultrasonography appears to be an ideal follow-up method to evaluate early transmural changes in disease activity, in response to medical treatment. Clinical trial no: DRKS00010805.

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