
Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis
Ulcerative ColitisThis is a Phase 1b, randomized, double-blind, multicenter dose-ranging study to evaluate the safety, tolerability, and PK of NX-13. Approximately 40 subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 NX-13 treatment regimens (NX-13 250 mg IR, 500 mg IR, 500 mg MR) (12 evaluable subjects at each of the 3 dose levels) or placebo (4 subjects), once daily for 28 consecutive days.

Ulcerative Colitis Mayo Score With Artificial Intelligence
Ulcerative ColitisColonoscopy1 moreThis project will use deep learning to classify colonoscopy images of different severity of ulcerative colitis, so as to assist clinicians in the accurate diagnosis of ulcerative colitis.

Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis
ColitisUlcerativeThe purpose of this study is to investigate the efficacy and safety of vedolizumab intravenous (IV) dose optimization on mucosal healing compared with the standard vedolizumab IV dosing regimen over a 30 week treatment period in participants with moderately to severely active ulcerative colitis (UC) and high vedolizumab clearance, based on a Week 5 predefined serum vedolizumab concentration threshold less than (<) 50 microgram per milliliter (microg/mL) and who are Week 6 non-responders based on partial Mayo score.

An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous...
ColitisUlcerativeThe purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.

Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis...
Ulcerative ColitisThe purpose of this study is to determine whether etrasimod (APD334) is a safe and effective treatment for ulcerative colitis after 52 weeks of treatment.

Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis...
ColitisUlcerative1 moreThe purpose of this study is to assess the concentration of vedolizumab in breast milk of lactating women with active ulcerative colitis (UC) or Crohn's disease (CD) who are receiving vedolizumab therapeutically.

Budesonide 9 mg Capsules in Active UC
ColitisUlcerativeThe purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis

Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease
Inflammatory Bowel DiseasesCrohn Disease2 moreA series of N-of-1 trials will be used to determine the effectiveness of a specific carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and inflammatory burden at both the individual and population level. This is a four-year study. The study staff will recruit up to 60 patients across up to 21 sites in patients aged 7-18 with mild to moderate disease activity.

BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis...
ColitisUlcerativeThis trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II) to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III) To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the target population to be evaluated in study 1368-0020.

Fecal Microbiota Transplantation for Severe Clostridium Difficile Infection
Clostridium DifficilePseudomembranous ColitisFecal microbiota transplantation (FMT) is acknowledged as a highly effective treatment for recurrent Clostridium difficile infection (CDI). Usually single fecal infusion achieves satisfactory cure rates of recurrent CDI). However, several retrospective studies show that severe clinical picture of recurrent CDI is a risk factor for the failure of single-infusion FMT, suggesting that multiple fecal infusions are required to cure this condition. This is an open-label randomized clinical trial aiming to assess if multiple-infusion FMT is more effective than single-infusion FMT in curing severe CDI