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Gut bacteria pill for colitis shows early promise, but trial stopped early

NCT ID NCT05370885

Disease control Sponsor: Vedanta Biosciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental oral treatment called VE202 for people with mild-to-moderate ulcerative colitis, a chronic inflammatory bowel disease. The treatment uses live bacteria to help restore gut balance. The trial was terminated early, so results are limited. Participants took VE202 or a placebo for 2 or 8 weeks, and researchers looked at safety and whether the treatment improved colon inflammation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

114 people

The number who actually took part.

Started

May 2023

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

KEY INCLUSION CRITERIA 1. 18 to 75 years of age 2. Documented clinical and endoscopic diagnosis of UC at least 3 months prior to randomization 3. Active mild to moderate UC, as defined by the following: 1. Disease that extends at least 15 cm from the anal verge 2. A modified Mayo score of 4 to 8 with: (i.) Mayo endoscopic subscore of ≥ 2 based on screening flexible sigmoidoscopy; (ii.) Rectal bleeding score of ≥ 1 4. Has never received a biologic agent, Janus kinase inhibitor, or sphingosine-1-phosphate modulator for the treatment of UC 5. If receiving corticosteroids, dose must be stable for at least 4 weeks before randomization 6. Doses of other allowable UC medications must be stable for at least 8 weeks before randomization KEY EXCLUSION CRITERIA 1. Known history of Crohn's disease (CD) or indeterminate colitis 2. A known diagnosis of primary sclerosing cholangitis 3. Allergy to VE202 or any of its components 4. Allergy to vancomycin or any of its components 5. A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac disease, parasitic infection) within 3 months prior to randomization 6. Use of probiotics or herbal, botanical, or traditional medicinal preparations within the 2 weeks prior to randomization (consumption of food products such as yogurt, kefir, kombucha, and herbal teas is permissible) 7. Receipt of Fecal Microbiota Transplantation (FMT) or other fecal-derived preparation within 6 months prior to randomization 8. Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy) 9. Receipt of any investigational biologic within 60 days or 5 half-lives prior to randomization, whichever is longer

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colitis ulcerative Ulcerative colitis

Contacts and locations

Locations

  • Artes Medikum, Medial Center, Llc

    Kyiv, 02002, Ukraine

  • Atlanta Center for Gastroenterology, P.C. & Atlanta Endoscopy Center, LTD

    Decatur, Georgia, 30033-6146, United States

  • Barts Health NHS TrustThe Royal London Hospital

    London, E1 2AJ, United Kingdom

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Bonifraterskie Centrum Medyczne Sp. z o.o

    Lodz, Łódź Voivodeship, 93-357, Poland

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Centrum Medyczne "MEDYK"

    Rzeszów, Podkarpackie Voivodeship, 35-326, Poland

  • Chernivtsi Regional Clinical Hospital

    Chernivtsi, 03110, Ukraine

  • Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Spółka komandytowa

    Poznan, Greater Poland Voivodeship, 61-731, Poland

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139, Australia

  • Cornell University Weill Cornell Medicine New York Presbyterian Hospital

    New York, New York, 10021, United States

  • Dept. Gastroenterology, Univ. Debrecen

    Debrecen, H-4032, Hungary

  • Endoskopia Sp. z o.o.

    Sopot, Pomeranian Voivodeship, 81-756, Poland

  • GI Pros Research

    Naples, Florida, 34102, United States

  • Gastroenterology Research of America, LLC

    San Antonio, Texas, 78229, United States

  • Imperial College Healthcare NHS Trust - St Mary's Hospital

    London, W2 1NY, United Kingdom

  • King's College Hospital

    London, SE5 9RS, United Kingdom

  • LLC Medical Center "Consilium Medical"

    Kyiv, 04050, Ukraine

  • Leiden University Medical Center

    Leiden, 2333 ZA, Netherlands

  • M.Sklifosovsky Poltava Regional Clinical Hospital Regional Gastroenterology Center

    Poltava, Poltavska, 36011, Ukraine

  • MEDICAL NETWORK Sp. z o.o. WIP Warsaw IBD Point

    Warsaw, Masovian Voivodeship, 04-501, Poland

  • Mater Misericordiae Ltd and Mater Research Ltd

    South Brisbane, Queensland, 4101, Australia

  • Medical Center OK!Clinic+

    Kyiv, 02091, Ukraine

  • Medical Centre Asklepion Main

    Sofia, 1303, Bulgaria

  • Medrise Sp. z o.o.

    Lublin, Lublin Voivodeship, 20-582, Poland

  • Municipal Nonprofit enterprise Kyiv City Clinical Hospital # 18

    Kyiv, 01054, Ukraine

  • NYU IBD Center

    New York, New York, 10016, United States

  • National Institute of Surgery and Transplantology named after O. O. Shalimova

    Kyiv, 03126, Ukraine

  • Pannónia Magánorvosi Centrum Kft

    Budapest, 1136, Hungary

  • PreventaMed s.r.o, Vila zdraví

    Olomouc, 77900, Czechia

  • Radboud Universitair Medisch Centrum

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • Regional Clinical Hospital of the Ivano-Frankivsk Regional Council

    Ivano-Frankivsk, 76000, Ukraine

  • Revival Clinical Research

    Orlando, Florida, 32807, United States

  • Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika

    Budapest, 1088, Hungary

  • Solumed Centrum Medyczne

    Poznan, 60-529, Poland

  • St Vincent's Hospital Melbourne Department of Gastroenterology

    Fitzroy, Victoria, 3065, Australia

  • Ternopil Regional Clinical Hospital

    Ternopil, 46002, Ukraine

  • Transcarpathian Regional Clinical Hospital named after Andria Novak

    Uzhhorod, 88018, Ukraine

  • UHB NHSFT Queen Elizabeth Hospital

    Birmingham, West Midlands, B15 2TH, United Kingdom

  • UMHAT Medica Ruse OOD

    Rousse, 7013, Bulgaria

  • University of Utah Hospitals and Clinics

    Salt Lake City, Utah, 84132, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

  • Uzhgorod City Multidisciplinary Clinical Hospital

    Uzhhorod, 88009, Ukraine

  • Vilnius University Hospital Santaros klinikos

    Vilnius, LT-08661, Lithuania

  • Vinnytsia City Clinical Hospital No. 1

    Vinnytsia, 21029, Ukraine

  • Vinnytsia Regional Clinical Hospital named after M.I. Pirogov

    Vinnytsia, 21000, Ukraine

  • Vita Longa Sp. z o.o.

    Katowice, 40748, Poland

  • Vojenská nemocnice Brno, Interní oddělení

    Brno, 61500, Czechia

  • Volyn Regional Clinical hospital

    Lutsk, 43000, Ukraine

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