This trial is evaluating whether CDPATH™ will improve 1 primary outcome and 8 secondary outcomes in patients with Ileocolitis. Measurement will happen over the course of Baseline (Day 1).
This trial requires 200 total participants across 2 different treatment groups
This trial involves 2 different treatments. CDPATH™ is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.
Although it is not fully understood, ulcerative colitis may be caused by a combination of a number of factors, including a disturbance in the integrity of the gut mucosa. The mechanisms behind this may involve genetics to some extent but, in our opinion, environmental factors such as diet and smoking are also important.
It appears that up to 70,735 inpatient cases of ileocolitis occur in the US annually. These cases represent <1% of all hospitalizations involving the inflammatory bowel. The data should be useful in developing patient education programs and in the design of prospective, randomized studies.
There has not been a single report of the efficacy of a treatment for UC in any randomized placebo-controlled research study conducted to date. We believe that the findings of this study (along with those of the previously published studies) lend strong weight to the view that UC is a lifelong, unresponsive inflammatory bowel disorder and that current therapeutic strategies are not efficient nor safe. The findings also suggest that further research into pharmacotherapy for UC is warranted.
Diagnosis of UC through symptoms can be made in a large proportion of patients. In patients with rectal bleeding or colo-anal ulceration, endoscopy detects the colitis in most. In patients without severe rectal bleeding, colonoscopy helps in excluding colitis even in those with unremarkable symptoms.
Ileocolitis commonly represents inflammation of both the colon and the ileum (the latter often being more predominant) in inflammatory bowel disease, especially in ulcerative colitis and Crohn's disease, in the absence of an intestinal worm infestation. It may be an important and understudied component of mixed (ulcerative colitis + Crohn's disease), in this sense similar to the pouchitis encountered more commonly with pouch-Anal anastomosis.
Patients may be treated with lactulose, probiotics, colitis-specific oral medication, or cimetidine. Additional treatment for those patients intolerant of lactulose includes a low-calorie diet, budesonide enema, or mesalamine. In severe cases of ileocolitis, surgery may be required. In this paper, we discuss the treatments for ileocolitis.
CDPath™ is effective and safe in treating ileocolitis. It results in resolution of symptoms, increased participation in activities and satisfaction with life while improving quality of life and enhancing the patient's perceived control.
After reviewing medical literature and comparing manufacturer claims to data submitted to United States Food and Drug Administration's Center for Devices and Radiological Health, we concluded that our patient was undergoing treatment with cdpath™. Recent findings's findings support the manufacturer's marketing claims for cdpath™.
A small group of patients have a poor outcome from ileocolitis. Current treatment approaches fail to meet the needs of these patients and new therapies are needed.
Between the ages of 5 and 25 years, an average of three quarters of patients has some form of ileocolitis. The mean age of first ileocolitis is 19.9 years (11.5). Ileocolitis occurs more often in males than in females, most commonly between 20 and 39 years of age. The incidence is probably decreasing, and the most common age at which patients develop ileocolitis is probably between the ages of 40 and 50 years of age.
All ileocolitic patients had a history of pouch surgery, although the exact incidence of pouch surgery needs to be more precisely defined. Therefore, this condition should not be considered a complication of pouch surgery. Primary causes of ileocolitis are colonic stenosis, pouchitis, or both.
The cdpath device has been improved through three iterations in the last five years and [https://www.cdpath.net/en/about.html is now available as an alternative to surgical resection for treating ulcerative and stricturing forms of ileocolitis. Clinical benefits and [efficacy and tolerability are well established for ileal pouch surgery when cdpath™ has been studied.[Power] is very helpful for finding cdpath studies near you.