View clinical trials related to Colitis.
Filter by:The purpose of this study is to determine whether a diet intervention (the Fasting Mimicking diet) will help induce clinical and biochemical response to tofacitinib therapy or second line biologic therapy with ustekinumab or infliximab in patients with ulcerative colitis. Study period will be 8 weeks during induction of tofacitinib or ustekinumab or infliximab. The primary aims of this study are to determine clinical response and improvement in fecal calprotectin and C-reactive protein levels. Secondary outcomes will include assessment of changes in the stool microbiome.
The purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of PN-943 450 mg twice daily [BID] and PN-943 150 mg BID, compared with placebo BID, in subjects with moderate to severe active Ulcerative Colitis (UC).
The prevalence of ulcerative colitis (UC), which is one of the inflammatory bowel diseases, is known to be increasing and the majority of patients (≥ 85%) have experienced mild or moderate severity. 5-Aminosalicylic acid (5-ASA), immunomodulator, or biologics, etc are prescribed to treat UC, however 5-ASA is generally considered the first-line therapy. The recent UC treatment guideline in Korea and the United States/ European Union (US/EU) have recommended higher daily dose for patients with mild or moderate severity than the previous guidelines since 2017. Accordingly, it is assumed that the average daily treatment dose of 5-ASA would increase in patients who were initially diagnosed with UC in real-world clinical practice in Korea. However, there are not many studies evaluating the treatment patterns and health outcomes of 5-ASA based on the recent treatment guideline in South Korea. This study, hence, aims to investigate the impact of changes in daily dose of 5-ASA on the treatment patterns and health outcomes such as recurrence rate, hospitalization rate, and surgery rate in real world practice using Health Insurance Review and Assessment (HIRA) claims database.
This is an open label, single-arm, proof of mechanism study to explore the efficacy and safety of rectally administered BBT-401-1S in subjects with ulcerative colitis.
A)Background: Approximately 44% of patients with Inflammatory bowel disease have Ulcerative colitis(UC) which is a lifelong, chronic disease, starting in early adulthood, where the colon becomes inflamed and ulcerated due to a complex interaction between genetics, altered immune function, and environmental factors2such as dietary intake. While the etiology of UC is not clear, it is hypothesized the abnormal immune response and chronic inflammation may be caused by dysbiosis of the intestinal microbiota and decreased epithelial barrier function. Substantial evidence suggests that higher than normal levels of hydrogen sulfide (H2S) in the colon plays a role in the etiology of UC. The higher levels of H2S and sulfate-reducing bacteria (SRB) found in the feces of patients with UC is likely caused by the reduced conversion of H2S to thiosulfate by rhodanese (thiosulfate transferase enzyme)12, and increased colonization or activity of SRB. For example, SRB has been identified as the predominant bacterial group in patients with UC compared to the minority group in healthy individuals, and SRB growth is stimulated by the presence of sulfur-rich amino acids. Dietary intervention may help to repair the dysbiosis existing in the microbiome of the patient with UC, but research about food and recurrence of UC is conflicting. Dietary components such as sulfur and sulfates also appear to play a role in the recurrence of UC; although a recent review of the relationship between sulfur-containing foods and UC calls for more randomized controlled trials (RCTs) examining a reduced sulfur diet in UC. With the body of evidence described above, there is a compelling reason to consider that sulfur and sulfate-containing foods contribute to developing severe UC. Thus, understanding how dietary modulation of sulfur intake within the context of UC impacts disease status is the focus of this proposal.
The purpose of this study is to evaluate if study drug mirikizumab is safe and effective compared to vedolizumab and placebo in participants with moderately to severely active ulcerative colitis (UC).
This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part A) followed by a multiple ascending dose (MAD) part (Part B). The decision to escalate between dose levels and proceed to Part B will be based upon review of blinded available safety data by a Safety Review Committee.
The purpose of this study is to evaluate safety and tolerability of JNJ 66525433 compared with placebo after administration of: 1) single ascending oral doses of JNJ 66525433 administered to healthy participants (Part 1), 2) multiple, ascending oral doses of JNJ 66525433, administered to healthy participants once daily over 14 consecutive days (Part 2), and 3) multiple oral doses of JNJ 66525433, administered once daily over 14 consecutive and once daily over 42 consecutive days in participants with ulcerative colitis (UC) (Part 3).
Ulcerative colitis (UC) is characterized by a disrupted homeostasis of the commensal bacterial population (dysbiosis). A promising therapy for restoration of the altered balance of the enteric microbiota is fecal microbial transplantation (FMT). FMT will ameliorate colitis via alterations of patients' microbiota and their proteolytic-dependent effect on epithelial permeability. Design: 80 patients will undergo 1:1 randomization for multiple FMT (Fecal Microbiota Transplantation) from a healthy donor or autologous (placebo) through colonoscopy and rectal enemas. The treating physicians and the patients will be blinded for the treatment arm. At the FMT visit (first week), blood and stool samples will be taken and patients will be filling out questionnaires to assess disease activity level. Every 2 weeks patients will come to a clinic for a follow up visit. 8 weeks after FMT, patients will undergo sigmoidoscopy to assess disease severity, biopsies will be taken as well.
This is an observational prospective study with two years of follow-up, designed to evaluate the effectiveness of tofacitinib in patients with moderate to severe ulcerative colitis in French clinical practice