Asacol, which is mesalamine - derivative of 5-aminosalicylic acid. It is prsecribed for treatment and remission maintenance at patients with ulcer colitis (earlier known as nonspecific ulcer colitis) of mild and moderate type.
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Asacol, which is mesalamine - derivative of 5-aminosalicylic acid. It is prsecribed for treatment and remission maintenance at patients with ulcer colitis (earlier known as nonspecific ulcer colitis) of mild and moderate type.
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Pentasa for colitis, a recurring, inflammatory bowel disease, and is a promising vaccine candidate to prevent this condition," says M.V. Ramakrishnan, Associate Professor of Gastroenterology at the University Washington Medical Center. "It is a promising and candidate to prevent ulcerative colitis (UC). If it helps, we know there are a lot of people who need it," he adds, "It's a long battle to get vaccine the clinic because it's difficult. But there certainly are patients who benefiting from colitis benefit S. pulex. People can be cured of a disease if they have vaccine, so the whole world can participate in that." The first clinical trials of Colaxx are underway and an approval for the vaccine is expected within year. The study was led by Ramakrishnan in collaboration with collaborators from the University College of London and The University Liverpool. These investigations were reported in the Journal of Gastroenterology, published online last week, and appeared in print this week. Colitis patients can suffer a spectrum of conditions, including an active intestinal infection, and can also develop coliform bacteria—the bacteria responsible for diarrhea. Although the vast majority of patients have no signs or symptoms, around one-third develop colitis after two to six years of having an active infection—and over half develop signs or symptoms within the first three to six years of infection. This study included 48 individuals with UC and an unrelated cohort, of whom 29 were affected by UC and five colitis. Participants included those diagnosed with UC or without colonic polyps in their colon during first visit to hospital. Participants were screened and then randomly assigned into the S. pulex plus or placebo groups. Both groups underwent a colonoscopy during period of three months. During the study, participants were given tablets containing 5,000 colony-forming units (CFU) of S. pulex every eight months for a year. Colonic and liver inflammation, changes in the gene expression of certain genes relevant to inflammation and disease development, were monitored. These samples taken at 12, 24, 36 and 60 months, analyzed at eight time points throughout the course of study. At baseline, there was no significant difference in colonic inflammation or biomarkers; however, at 60 months, all groups demonstrated reductions in colonic inflammation with both Colaxx and S. pulex, with a trend to reduce colonic inflammation with S. pulex alone at 24 hours post-dose, suggesting that S. pulex may have beneficial effects through its on inflammation at the molecular level within colon. The researchers found that after 12 months, the disease severity of participants in the placebo group, including those with the active UC diagnosis, decreased by 30 to 50 percent more than participants who were in the placebo group at 60 months. The researchers hypothesize that this may be due to S. pulex's prevention of colitis-dependent inflammation. "The next question we had was why S. pulex works," says Ramakrishnan, who also serves as director of the UW Gastrointestinal Pathology Core. "We knew that we had a really significant effect through the gut mucosa on inflammation—not just from colonic inflammation—but what we were trying to uncover was exactly what it was." By using S. pulex to target a gene called COX-2, they discovered that the disease severity in participants receiving Colaxx decreased by an average of 56 percent more than participants in the placebo group who were still in the same state of disease, meaning that reducing COX-2 activity may help to prevent both UC and colonic inflammation. Previous studies using COX-2 inhibitors were unable to demonstrate any effect in reducing inflammation. The new findings in this pilot Phase II trial provide further support for the development of a therapeutic agent for disease prevention using S. pulex. "What we hope is that this work will lead to studies in animals," Ramakrishnan says. "We are not doing human studies now, but in a few months we will, and then want to move into studies that are much larger, to test whether S. pulex can decrease inflammation in large numbers. If it can reduce disease severity and possibly the need for surgery, perhaps one day people can be cured. A lot of people have this disease, and some can get it if they early enough, and you really can cure it. And if you can get it early enough, you might be able to prevent it." The study's principal investigator is Jelena Popovici, PhD, of the University College London. study's co-principal investigators are Aravind Bhatnagar, PhD, and Dina El-Yamel, MD, both from The University of Liverpool;
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