Evidence types
Phase 1 clinical trial articles covering early human safety, dosing, and first-in-human treatment research relevant to IBD.
Page 1 of 3 · 124 articles
The trial evaluated an investigational, non-drug vagal nerve stimulation device as a potential therapy for ulcerative colitis in adolescents and young adults, which could expand treatment options beyond conventional...
The study aims to clarify differences in visceral sensitivity and collect multiple biological samples that could help explain why some people with IBD have IBS-like symptoms. Findings could inform better symptom-targeted...
Malnutrition is common in IBD and linked to worse quality of life and outcomes. Validating a standardized GLIM approach could help clinicians identify and treat malnutrition earlier and more consistently in people with...
Distinguishing inflammation from irreversible fibrosis is a common clinical challenge in Crohn’s disease because it affects treatment choices (medical therapy versus surgery). Validated MRI biomarkers could improve...
This trial tested a new monoclonal antibody directed at TLR3 in moderate-to-severe ulcerative colitis to see if it is safe and biologically active.
This report describes early human evidence that an oral, gut-targeted PDE4 inhibitor (PALI-2108) may reduce intestinal inflammation and improve endoscopic findings in people with Crohn's disease and ulcerative colitis —...
Early-phase data suggest PALI-2108 reaches the ileum and colon and produced rapid reductions in endoscopic inflammation and fecal calprotectin in small Phase 1b cohorts—results that could matter if confirmed in larger...
This trial explores whether delivering sodium propionate directly to the colon can alter the gut microbiome and immune markers in people with Crohn’s disease and whether it offers similar or added benefits compared with...
Dietary patterns, especially ultra-processed food intake, are increasingly linked to Crohn's disease activity. This trial could provide randomized evidence on whether reducing ultra-processed foods prolongs remission in...
This trial is testing a novel stem-cell infusion approach aimed at treating Crohn’s disease and ulcerative colitis, so people with IBD may be interested in emerging cell-therapy options and safety data. Phase 1 studies...
An oral biologic study could offer a new treatment approach for people with moderate–severe ulcerative colitis; the trial is evaluating safety and multiple measures of disease activity including endoscopy and histology.
This study aims to measure how much time people with ulcerative colitis spend with objectively uncontrolled inflammation and to compare real-world outcomes of different initial advanced-therapy choices and...
The trial tests a naturally derived oral supplement (WPMDE2) in patients with ulcerative colitis, measuring symptoms, inflammatory markers, and quality of life—outcomes that matter to people living with IBD. Early-phase...
This early-phase trial explores a novel, targeted bacteriophage treatment for pouchitis linked to an Aeromonas-associated pathogen (MTB). For people with pouchitis after IPAA, a safe, effective phage therapy could...
People with Crohn’s disease or ulcerative colitis may have higher cardiovascular risk; this prospective study aims to measure how often major heart and vascular events occur in IBD and to find biological and clinical...
Researchers are investigating whether a specific gut bacterium (Pilosibacter rotomagensis) is linked to lower intestinal inflammation after surgery for ileal Crohn's disease. If true, this could point toward new...
Early human data suggest PALI-2108 reaches intestinal tissue and produced short-term clinical, endoscopic, and biomarker changes in very small Phase 1 cohorts, supporting larger Phase 2 trials that could determine if...
Early Phase 1 findings suggest a gut-targeted PDE4 prodrug may engage its target in diseased tissue and produce early improvements in symptoms, endoscopy, and tissue inflammation — findings that, if confirmed in Phase 2,...
The study is collecting genetic and clinical data to identify genes that may contribute to IBD risk across populations — information that could inform future research, risk prediction, and understanding of disease...
Fatigue is a common, impactful symptom in Crohn's disease with limited targeted treatments. This early-phase trial is testing whether CoQ10 supplements might reduce fatigue and could inform larger placebo-controlled...
If validated, early bedside ultrasound changes could let clinicians identify within days whether steroids or biologics are working, enabling faster treatment adjustments and potentially avoiding prolonged ineffective...
Vitamin D deficiency is common in people with IBD and can affect bone health and possibly immune function.
People with ulcerative colitis and their clinicians may find real-world safety and disease-activity data helpful when deciding about upadacitinib (Rinvoq) treatment. Observational registries can reveal how a drug...
Early, easily available blood markers that predict mucosal healing could help clinicians decide sooner whether a new or intensified therapy is working, potentially reducing prolonged ineffective treatment and guiding...
Researchers are testing a new swallowable thermal capsule that could eventually help detect temperature changes from GI inflammation. For people with Crohn’s disease or IBD, a safe, noninvasive way to sense inflammatory...
This registry will collect real-world data on guselkumab use in adults with moderate-to-severe Crohn's disease or ulcerative colitis, focusing on how long patients stay on treatment, effectiveness in routine practice,...
People with Crohn's disease often ask whether food additives and artificial sweeteners affect gut microbes or disease activity. This trial directly tests whether sucralose changes the fecal microbiome in adults with...
If gut microbes produce LPC/LPA that are linked to chronic abdominal pain, it could point to new biomarker or microbiome-targeted approaches for unexplained pain in IBD patients whose inflammation is quiet or minimal.
This press release signals a step toward a new local, regenerative approach for treating complex perianal fistulas—a difficult Crohn’s complication with limited options. If clinical trials proceed, the therapy could add...
Understanding why some IBD ulcers fail to heal could help researchers develop better treatments or biomarkers to predict healing, which matters because mucosal healing reduces hospitalizations, surgeries, and cancer...
This project targets epithelial repair — a mechanism not directly addressed by most current IBD drugs — and reports early human safety/tolerability data, so it could lead to a new oral therapy for inducing and...
Dietary approaches that reduce gut inflammation could offer a low‑risk option to help manage symptoms and biomarkers in Crohn’s disease. This trial specifically tests a catered anti‑inflammatory diet and measures fecal...
Real-world registry data on upadacitinib can help patients and clinicians understand how the drug performs outside clinical trials, including patterns of use, effectiveness, and safety over time.
A new oral investigational drug (TP317) is entering a Phase 1b study in adults with active UC to assess safety and pharmacokinetics, which may be relevant to patients seeking information about emerging therapies.
Understanding how patient-derived epithelial cells respond to inflammation could reveal mechanisms of poor mucosal healing in IBD and identify targets or biomarkers to improve repair. Organoid models from patient tissue...
This project describes a novel off-the-shelf engineered regulatory T cell therapy aiming to promote intestinal immune regulation and mucosal healing — a different approach than current biologics. If successful, it could...
Researchers are testing whether blocking three inflammation pathways at once can reduce tissue inflammation more than single drugs. If ex vivo results show stronger effects, it could guide development of multi-target...
Postoperative recurrence is common after intestinal resection for Crohn's disease, but clinicians currently lack reliable molecular biomarkers or validated models to predict who will relapse.
This trial tests a novel, tissue-derived cell therapy applied directly to intestinal ulcers — an approach that could lead to new local healing treatments for people with Crohn’s disease if proven safe and effective.
Researchers are studying how proteins from both the host and microbes in the gut relate to Crohn’s disease features. Findings could point to new noninvasive biomarkers or therapeutic strategies to correct dysbiosis,...
This trial represents an early-stage clinical test of a new investigational drug (ATTO-1091) for people with ulcerative colitis; Phase 1 studies establish initial safety and how the drug behaves in the body, which are...
The study aims to map the specific peptide targets of T cells driving organ inflammation in autoimmune diseases, which could guide development of antigen-specific, tolerogenic treatments relevant to Crohn's disease and...
Psychological distress and gut–brain interactions can worsen quality of life and IBD outcomes. A culturally tailored, scalable digital mind–body program could improve access to psychosocial care for Black and Hispanic...
People with IBD who are treated with anti‑TNFα drugs commonly develop inflammatory or infectious skin problems. This study aims to clarify whether Staphylococcus aureus is more abundant in those lesions and whether its...
Intestinal ultrasound can assess IBD inflammation without radiation but interpretation varies by operator. Developing AI tools to measure bowel wall thickness and other features could standardize and speed image...
Stress and psychological distress are common in people with IBD and may influence symptoms and inflammation. This trial tests whether an 8‑week MBSR program can improve psychological wellbeing and whether those benefits...
People with stricturing Crohn’s disease currently lack effective medical treatments to prevent or reverse intestinal fibrosis; this trial explores a probiotic approach (and trehalose) aimed at stimulating autophagy, a...
Drug developers use mass-balance (ADME) studies to learn how a new drug is absorbed and cleared, which helps guide dosing, safety testing, and further trials.
