This trial is evaluating whether Bezlotoxumab will improve 1 primary outcome and 3 secondary outcomes in patients with Inflammatory Bowel Diseases. Measurement will happen over the course of 8 weeks.
This trial requires 120 total participants across 2 different treatment groups
This trial involves 2 different treatments. Bezlotoxumab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
Approximately 450,000 people have IBD annually in the United States. The prevalence of IBD is higher in the United States than other regions of the world.
Despite the high level of agreement among experts' results, the degree of cure of patients with moderate to severe IBD is not as good as that for patients with mild IBD.
Symptoms of IBD are present from birth. Patients with question: What can we say about the impact of a physical examination on care planning? answer: Physical examination was not a useful adjunct to a question: Do patients'expectations of treatment have any predictive value? answer: Patients did not have significant expectations of benefit from a physical examination.
Inflammatory bowel disease can be divided into ulcerative colitis and Crohn disease. Only in 5%, each of ulcerative colitis (UC) and Crohn disease (CD) are the indications for surgery (mainly ileocaecal resection and total colectomy). On the other hand, 5-year mortality is 5% for UC and 10% for CD. The main prognostic factor is a short time interval from diagnosis to follow-up visit due to the long-lasting effects of the diseases. The lifetime risk of developing UC in a Caucasian is 1.9 and 2.5 in a Danish population.
While there is no effective treatment for irritable bowel syndrome, common treatments generally work well, and many patients have a good long-term outcome. However, certain patients may have a limited benefit from treatment and many patients benefit less from treatment.
Many different autoimmune diseases may be triggers for Crohn's disease, Ulcerative colitis and/or a combination of them. Infections and immune changes during pregnancy may be the triggering factors in Crohn's disease. Allergic reactions may also be a cause for Crohn's disease. Also, a chronic viral or bacterial infection (chronic hepatitis B virus and Epstein-Barr virus infections in particular) may cause a Crohn's-like disorder. Allergic diseases such as allergic bronchopulmonary aspergillosis and hypersensitivity angiotensin II-converting enzyme inhibitors) may act merely as a trigger of inflammatory bowel diseases. Also, infections may be a trigger of ulcerative colitis.
There are four clinical trials showing proof of concept for the effectiveness of bezlotoxumab, and three trials showed efficacy beyond that of a placebo, when the clinical effect was assessed according to MTC1 guidelines recommended by IBD European task force.
Most patients did not seek medical care for their inflammatory bowel disease. Patients with IBD who did seek treatment are likely hospitalized and have complications more often than patients without IBD. They are also more likely to have comorbidities and poor health-related quality of life.
Most IBD clinical trials are in adult patients. Younger patients are more likely to have a disease that's more dangerous and more likely to progress. Patients in critical care settings are also more likely to be enrolled in trials. For future clinical trials in IBD, a more rigorous approach should be used to exclude the aforementioned patients with risk factors and identify the most appropriate age group.
In our population bezlotoxumab was well tolerated and demonstrated improvements in both depression and bowel function during the treatment period. More participants had good response on anxiety, and overall there was no statistically significant increase in adverse events. Future controlled studies combining bezlotoxumab with standard therapy, should be conducted in order to validate further these results.
Bezlotoxumab treatment did not improve quality of life compared with placebo in patients with moderate-to-severe ulcerative colitis or Crohn's disease. Results from a recent paper are reassuring for patients and a new indication for bezlotoxumab.
Clinical trials are underway involving bezlotoxumab, such as bezlotoxumab in patients with moderate to severe Crohn's disease (CD) and moderate to severe ulcerative colitis (UC). It is anticipated that clinical trials on bezlotoxumab may open new perspectives on the treatment of inflammatory bowel diseases.