Ulcerative colitis causes ongoing inflammation and ulcers in the colon, leading to bleeding, diarrhea, and abdominal pain. About 1 million Americans have it. Treatment has expanded from older immunosuppressants to targeted biologics and small-molecule drugs that can put many people into remission.
What's actually going on in research
Trials are testing JAK inhibitors, anti-integrin antibodies, IL-23 inhibitors, S1P receptor modulators, and stem cell therapies. Many studies compare new drugs to vedolizumab or adalimumab, which are now standard options. Researchers are also pursuing therapies that restore the intestinal barrier and microbiome treatments that address underlying gut imbalances.
JAK inhibitors
Pills like tofacitinib and upadacitinib are FDA-approved for ulcerative colitis and block inflammation inside immune cells. Newer JAK inhibitors are being tested to see if they work faster or have fewer side effects.
IL-23 pathway blockers
Drugs targeting IL-23, a protein that drives intestinal inflammation, showed strong results in Crohn's disease. Trials are now testing whether they work as well in ulcerative colitis.
Microbiome therapies
Studies are testing fecal transplants and engineered bacterial treatments to restore healthy gut bacteria. Early results suggest some people respond, but identifying who benefits remains a challenge.
What to know before you search
Eligibility usually depends on disease severity, how much of the colon is inflamed, response to past treatments, and results from recent colonoscopy.
What types of trials are currently open
- Induction trials — Testing whether a new drug can bring active ulcerative colitis into remission within weeks to months. Often compare the drug to a placebo or standard treatment.
- Maintenance trials — Testing whether a drug keeps people in remission long-term after initial response. May last a year or more.
- Head-to-head trials — Comparing two active drugs directly to see which works better or has fewer side effects.
- Combination trials — Testing whether using two drugs together works better than one alone, especially for people who didn't fully respond to one treatment.
- Biomarker studies — Following people to identify blood or tissue markers that predict who will respond to specific treatments.
Recently added Ulcerative Colitis trials
Fecal Microbiota Transplantation for Ulcerative Colitis Using Dai and Han Donors
This study is a randomized clinical trial evaluating fecal microbiota transplantation (FMT) for ulcerative colitis (UC) using healthy donors from two ethnic groups in Yunnan, China. UC is a chronic inflammatory bowel disease causing colon inflammation and ulcers. FMT transfers gut bacteria from a healthy donor to a patient to restore healthy intestinal microbiota. Previous research suggested that FMT using donors from the Dai ethnic group (a minority nationality in Yunnan with special dietary habits) may achieve better results than Han Chinese donors for UC. This study aims to confirm this finding and understand why. The investigators will recruit 200 UC patients (ages 18-60) and randomly assign them to two groups (100 each). One group will receive FMT from healthy Han donors; the other from healthy Dai donors. Patients will receive three FMT infusions via endoscopic intestinal tubing. Treatment effects will be assessed at 12 weeks using clinical scores (Mayo score), endoscopic scores (MES), inflammatory markers (fecal calprotectin, CRP, ESR), and intestinal barrier function tests. Stool samples will also be analyzed using metabolomics and metagenomics to identify key gut bacteria and metabolites linked to better outcomes, and laboratory experiments will be performed to verify how they reduce intestinal inflammation. The goal is to identify optimal donor characteristics for FMT in UC and uncover mechanisms that may lead to more personalized microbiota therapies.
Donate blood, stool, and tissue samples to predict inflammatory bowel disease risk
Brief Summary The aim of the FIBER study is to identify potential triggers associated with the later development of IBD (inflammatory bowel disease) based on baseline characteristics and biosamples (blood, urine, stool, saliva, and tissue). Aim 1: To identify clinical, demographic, and immunologic factors associated with an increased risk of developing IBD in family members of IBD patients. This aim will investigate the role of clinical factors (e.g., age of onset, gender, and family history), demographic factors (e.g., socioeconomic status, geographical location), and immune system markers (e.g., inflammatory cytokine profiles, immune cell populations) in predicting the likelihood of family members developing IBD over time. Aim 2: To examine dietary, environmental, and immunologic influences on the development of IBD in family members of IBD patients. This aim will explore how dietary habits (e.g., fiber, fats, processed foods), environmental exposures (e.g., smoking, pollution, and antibiotic use), and immune responses (e.g., changes in T-cell activation, inflammatory markers) contribute to the risk of IBD in family members. Aim 3: To analyze the multi-omic (metagenomic, transcriptomic, proteomic) cellular signatures of host and microbial signatures in family members of IBD patients and their association with IBD onset. This aim will investigate changes in the gut microbiome and immune-related gene expression profiles (transcriptomics) in family members. Specifically, the aim will focus on how shifts in microbial composition and host immune response genes (e.g., those involved in inflammation and epithelial barrier function) correlate with an increased risk of IBD development. Aim 4: To investigate the multi-omic (metabolomic, transcriptomic, proteomic) cellular signature of host and microbial signatures in family members to identify biomarkers predictive of IBD development. This aim will involve examining the metabolic, protein, and transcriptomic signatures (e.g., circulating cytokines, immune receptor expression) in blood, urine, or stool samples. The study will seek to identify early biomarkers from these profiles that can predict the onset of IBD, even in asymptomatic family members.
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