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Microbiome Modulator

VE202 for Ulcerative Colitis

Phase 2

Recruiting

Research Sponsored by Vedanta Biosciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented clinical and endoscopic diagnosis of UC at least 3 months prior to randomization

18 to 75 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Study Summary

This trial tests a new treatment for ulcerative colitis to see if it is safe, effective, and changes the gut bacteria.

Who is the study for?

This trial is for adults aged 18-75 with mild to moderate ulcerative colitis (UC) diagnosed at least 3 months ago. Participants must not have received certain UC treatments like biologics, and doses of other UC meds should be stable for 8 weeks. Exclusions include a history of Crohn's disease, allergies to VE202 or vancomycin, recent non-IBD diarrheal illnesses, use of probiotics or herbal preparations within 2 weeks before the trial, past fecal transplantations within 6 months, and any intestinal surgery except cholecystectomy or appendectomy.Check my eligibility

What is being tested?

The Phase 2 study tests the safety and effectiveness of VE202 in patients with mild to moderate UC. It also looks at how it affects gut microbiota. Patients will receive either VE202 with a placebo that mimics vancomycin or vice versa; some may get both placebos as controls.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones associated with clinical trials involving new drugs for UC might include gastrointestinal discomforts such as nausea and bloating, potential allergic reactions to components in the drug formulation, headaches, fatigue and possible changes in bowel habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was diagnosed with ulcerative colitis over 3 months ago.

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I am between 18 and 75 years old.

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My ulcerative colitis affects an area at least 15 cm from the anal verge.

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My ulcerative colitis is moderate to severe, with significant inflammation and bleeding.

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I have never taken biologic drugs or specific inhibitors for ulcerative colitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants with Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs) that are treatment-related or Serious Adverse Events (SAEs) that are treatment-related in Part 1 and Part 2 of the study.

Proportion of participants with endoscopic response on flexible sigmoidoscopy after 8 weeks of treatment with VE202 or placebo.

Secondary outcome measures

Change in Mayo score compared with baseline at Week 8 of Part 1 and Week 8 of Part 2.

Change in colonization with VE202 strains detected in feces at various time points in patients treated with 2- and 8-week courses of VE202.

Change in fecal calprotectin levels after 2- and 8-week courses of VE202.

+13 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment.Experimental Treatment4 Interventions

In Part 1 of the study, patients in Group B will receive VE202 placebo for 8 weeks. In Part 2 of the study, patients in Group B will receive VE202 for 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.

Group II: Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment.Experimental Treatment4 Interventions

In Part 1 of the study, patients in Group A will receive VE202 for 8 weeks. In Part 2 of the study, patients in Group A will receive VE202 placebo for 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vancomycin

FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vedanta Biosciences, Inc.Lead Sponsor

6 Previous Clinical Trials

1,104 Total Patients Enrolled

Media Library

VE202 (Microbiome Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05370885 — Phase 2

Ulcerative Colitis Research Study Groups: Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment., Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment.

Ulcerative Colitis Clinical Trial 2023: VE202 Highlights & Side Effects. Trial Name: NCT05370885 — Phase 2

VE202 (Microbiome Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05370885 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any enrollees currently participating in this research endeavor?

"Correct. Per the clinicaltrials.gov listing, this medical experiment is currently recruiting participants with a target of 100 individuals from 2 sites. The initial posting date was May 8th 2023 and it had its most recent update on May 22nd 2023."

Answered by AI

Is the trial open to individuals above a certain age?

"Eligibility for this trial is restricted to adults between the ages of 18 and 75. There are 73 studies available for individuals younger than 18, with 361 more suitable options existing for those over 65."

Answered by AI

What is the primary aim of this research endeavor?

"This clinical trial's primary outcome over a 8-week period is assessing the percentage of participants experiencing Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs). The secondary objectives are observing the endoscopic response at Week 8, recording treatment related TEAEs and SAEs alongside AESIs, and evaluating the amount of patients in remission after Weeks 1 & 2."

Answered by AI

What deleterious effects could this treatment cause?

"The safety rating of this treatment is assessed as 2. This evaluation was based on the fact that it is currently at Phase 2, meaning there are some supportive data for its security but none regarding efficacy."

Answered by AI

What requirements must potential participants meet to be eligible for the trial?

"An individual's eligibility for this clinical trial is dependent on having ulcerative colitis, and being between 18-75 years of age. The study will require around 100 participants in total."

Answered by AI

How many participants have been allowed to join this clinical investigation?

"That is correct. As per clinicaltrials.gov, this research study launched on May 8th 2023 and was recently updated on May 22nd the same year. 100 individuals are required to be recruited from 2 particular sites for the trial to commence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

VE202 in Patients With Mild-to-Moderate Ulcerative Colitis

2023. "VE202 in Patients With Mild-to-Moderate Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05370885.

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