VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
NCT05370885 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114
Last updated 2025-12-17
Summary
A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).
Conditions
- Ulcerative Colitis
- Colitis, Ulcerative
Interventions
- BIOLOGICAL
-
VE202
VE202 is a rationally defined, live biotherapeutic product for oral administration.
- DRUG
-
Vancomycin Oral Capsule
Vancomycin is an antibiotic used to treat or prevent infection
- OTHER
-
VE202 Placebo
VE202 Placebo
- OTHER
-
Vancomycin Placebo
Vancomycin Placebo
Sponsors & Collaborators
-
Vedanta Biosciences, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-08
- Primary Completion
- 2025-08-29
- Completion
- 2025-08-29
- FDA Drug
- Yes
Countries
- United States
- Australia
- Bulgaria
- Czechia
- Hungary
- Lithuania
- Netherlands
- Poland
- Ukraine
- United Kingdom
Study Locations
More Related Trials
-
A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis
NCT02618187 ·Status: COMPLETED ·Phase: PHASE1
-
Extended Treatment With Vancomycin for Clostridium Difficile Colitis
NCT00861887 ·Status: WITHDRAWN ·Phase: NA
-
Vancomycin vs. Nitazoxanide to Treat Recurrent C. Difficile Colitis
NCT00304889 ·Status: COMPLETED
-
Refined Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis (UC)
NCT04968951 ·Status: TERMINATED ·Phase: EARLY_PHASE1
-
Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease
NCT00384527 ·Status: TERMINATED ·Phase: PHASE3
-
Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea
NCT02801656 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea
NCT00034294 ·Status: COMPLETED ·Phase: PHASE2
-
Oral Vancomycin Vs Placebo in the Prevention of Recurrence of Clostridioides Difficile's Infection
NCT05320068 ·Status: COMPLETED ·Phase: PHASE3
-
Secondary Prevention of Clostridioides Difficile Using Vancomycin
NCT06979609 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Bacillus Velezensis DSM 33864 for Reduction of the Risk of Recurrent Clostridioides Difficile Infections
NCT05606159 ·Status: WITHDRAWN ·Phase: NA
-
A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
NCT02218372 ·Status: COMPLETED ·Phase: PHASE3
-
Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients
NCT03643887 ·Status: WITHDRAWN ·Phase: PHASE2
-
Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
NCT03462459 ·Status: COMPLETED ·Phase: PHASE2
-
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
NCT06237452 ·Status: RECRUITING ·Phase: PHASE3
-
Intracolonic Vancomycin Therapy in Severe C. Diff Colitis
NCT01346059 ·Status: TERMINATED ·Phase: NA
-
Dose-Confirmation, Immunogenicity and Safety Study of the Clostridium Difficile Vaccine Candidate VLA84 in Healthy Adults Aged 50 Years and Older. Phase II Study
NCT02316470 ·Status: COMPLETED ·Phase: PHASE2
-
Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics
NCT02951702 ·Status: COMPLETED ·Phase: PHASE4
-
Oral Vancomycin Followed by Fecal Transplant Versus Tapering Oral Vancomycin
NCT01226992 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
NCT01259726 ·Status: COMPLETED ·Phase: PHASE2
-
Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis
NCT02606032 ·Status: COMPLETED ·Phase: PHASE2
-
Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.
NCT03937999 ·Status: TERMINATED ·Phase: PHASE4
-
Bezlotoxumab Versus FMT for Multiple Recurrent CDI
NCT05077085 ·Status: WITHDRAWN ·Phase: PHASE4
-
First-in-human Study of VE303 in Healthy Adult Volunteers
NCT04236778 ·Status: COMPLETED ·Phase: PHASE1
-
Placebo Controlled Study of Fecal Microbiota Transplant (FMT) for a First or Second Episode of C. Difficile Infection in Adults Using a Frozen Encapsulated Inoculum
NCT02343328 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea
NCT00196794 ·Status: COMPLETED ·Phase: PHASE3