Study on VE303 for Preventing Recurrent C. difficile Infection in Patients

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What is this study about?

This clinical trial is focused on studying a condition known as Clostridioides difficile infection, often referred to as CDI. This infection can cause severe diarrhea and other intestinal issues. The study is testing a new treatment called VE303, which is a capsule containing live bacteria that are believed to help restore balance in the gut. The trial will compare the effects of VE303 with a placebo, which looks like the VE303 capsule but does not contain any active bacteria.

The purpose of the study is to see if VE303 can prevent the recurrence of CDI. Participants in the study will be randomly assigned to receive either VE303 or the placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. The treatment will be taken orally, and the study will last for several weeks, with follow-up checks to monitor the participants’ health and any recurrence of the infection.

Throughout the study, participants will be asked to attend regular visits, provide samples, and complete questionnaires to help researchers gather data on the effectiveness of VE303. The main goal is to determine if VE303 can reduce the rate of CDI recurrence by the end of the study period. Participants’ health and any side effects will be closely monitored to ensure safety and gather comprehensive results.

1 Enrollment

Eligibility is determined based on age and medical history related to Clostridioides difficile infection (CDI).

Participants must have a laboratory-confirmed episode of CDI and meet specific criteria related to age and risk factors.

2 Completion of Standard Care Antibiotic Therapy

Participants complete a course of standard care (SoC) antibiotic therapy for CDI, lasting between 10 to 21 days.

The choice of antibiotic is determined by the physician, and tapering of antibiotics is not allowed.

3 Randomization and Start of Study Drug

Participants are randomly assigned to receive either the study drug VE303 or a placebo.

The first dose of the study drug is administered on the last planned day of SoC antibiotic therapy or no later than one day after completion.

4 Study Drug Administration

Participants take the study drug in the form of oral capsules.

The capsules are visually identical, ensuring that neither the participant nor the study team knows whether VE303 or placebo is being administered.

5 Monitoring and Follow-Up

Participants are monitored for recurrence of CDI and any adverse events for up to 24 weeks.

Regular assessments include providing blood and stool samples, completing questionnaires, and attending study visits.

6 End of Study

The primary endpoint is the proportion of participants with laboratory-confirmed CDI recurrence through Week 8.

Secondary endpoints include the incidence of adverse events and the relationship between VE303 colonization and CDI recurrence.

Who Can Join the Study?

  • For Stage 1: Must be at least 12 years old (or 18 years in some countries) and have had a confirmed episode of Clostridioides difficile infection (CDI), with at least one previous occurrence in the last 6 months.
  • For Stage 2: Must be at least 75 years old with a confirmed episode of CDI, or at least 12 years old (or 18 years in some countries) with a confirmed episode of CDI and at least two of the following risk factors:
    • Age 65 or older
    • Kidney problems, shown by a specific test result
    • Regular use of a type of medication called a proton pump inhibitor (PPI) in the past 2 months and expected to continue using it
    • Previous CDI episode between 6 and 12 months before joining the study
    • Weakened immune system due to a disease or its treatment
    • Had an organ or stem cell transplant
  • For both Stage 1 and Stage 2: The CDI episode must include:
    • At least 3 loose bowel movements in 24 hours for at least 2 days
    • Symptoms started within 4 weeks before starting antibiotic treatment for CDI
    • A stool sample tested positive for CDI before or shortly after starting antibiotics
    • Diarrhea not likely caused by something else
  • For both Stage 1 and Stage 2: Must complete a course of antibiotics for at least 10 days, up to 21 days, and show improvement with fewer than 3 loose bowel movements per day for at least 2 days.
  • For both Stage 1 and Stage 2: If able to have children, must have a negative pregnancy test and agree to use effective birth control, remain abstinent, or have a partner who cannot have children.
  • For both Stage 1 and Stage 2: Must be able to take the first dose of the study drug on the last day of antibiotic treatment or the day after.
  • For both Stage 1 and Stage 2: Must have recovered from any severe CDI complications and be stable.
  • For both Stage 1 and Stage 2: Must be able and willing to follow study procedures, such as taking capsules, attending visits, providing samples, and completing questionnaires.
  • For both Stage 1 and Stage 2: Must provide written consent to participate, understanding the risks and benefits. If under 18, a legal guardian must also provide consent.

Who Cannot Join the Study?

  • Individuals who do not have a Clostridioides difficile infection. This is a type of bacterial infection that affects the intestines.
  • Participants who are not within the specified age range for the study.
  • Individuals who are not able to follow the study procedures or instructions.
  • People who have other medical conditions that might interfere with the study or its results.
  • Participants who are taking medications that could affect the study outcomes.
  • Individuals who are pregnant or breastfeeding.
  • People who have participated in another clinical trial recently.
  • Individuals who have a history of substance abuse or other factors that might affect their ability to participate in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium
Gyncentrum Sp. z o.o. Katowice Poland
Medicinski Centar Hipokrat-N EOOD Plovdiv Bulgaria

Other Sites

Site Name City Country Status
University Hospital Ostrava Ostrava Czechia
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Nantes Nantes France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
CHU Bordeauxt Bordeaux France
MBAL Dr. Ivan Seliminski – Sliven AD Sliven Bulgaria
Multiprofile Hospital For Active Treatment Sveti Nikolay Chuditvorets EOOD Lom Bulgaria
Nemocnice Kyjov prispevkova organizace Kyjov Czechia
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD Gorna Oryahovitsa Bulgaria
Checdjvfc Udbypgzrzsfqbm Sdzbiraab Woluwe-Saint-Lambert Belgium
Hiwjkoyk Udxyovnubwyei db A Cqtbij A Coruna Galicia Spain
Ujzrkzyrho Hooeikmh Czrqgbr Cologne Germany
Fqdfmjamep Idcxh Pikujtjriom Sfi Mrypmi Pavia Italy
Uyejwyhiwxkd Modvitj Cqasdwa Uwjlryz Utrecht The Netherlands
Htzsgtcx Cgacob Dx Bgymxcmmu Barcelona Spain
Fdyzkvvj Nomuofxes Bjyx Brno Czechia
Cgppwz Hbevuerlmeb Rjeyhhfo Ugurxzarqisjk Dc Tziiv Tours France
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Arupwvj Ozmkyhdeufx Uelbizdrcnywh Fstcshup Iy Dg Nrcyxe Naples Italy
Rhplki Mnobfdwdkcl Aarhus Denmark
Usfykuuqsc Oj Smmshm Szeged Hungary
Cnjtgi Hwuwjcutwo Ulpqkyhablafw Dk Stovw Anwgktn Eqzdvr Porto Portugal
Hckoajfr Dx Lk Sqjuq Cquc I Sjuk Pkw Barcelona Spain
Uqiztsotlygb Zjinfpxbwg Gfas Gent Belgium
Hjluditi Uwrysqmgbgfzo Ptwldu Dy Hpxrrx Ds Mbcnmceeqis Majadahonda Spain
Fuzwimnim Pkgh Ll Ibxczumzrbinn Bhuwcwzti Dxv Hkqsfhom Uizxhoiqxzhst Ln Pvc Madrid Spain
Cdai Cnglsy Cgwopcq Apidbespd Bitlc Afqdzrysqy Braga Portugal
Ferqqqqcqi Iusbu Scx Gdrotav Dsm Tcxcdhc Monza Italy
Oszmloxt Pdriezjkyj Bagwvft Gswoouxfpky Rome Italy
Anxptpw Otshywyxfae Ufqkdpseizcmn Pzuwdl Pisa Italy
Cxa Cvjtp Rrzwzibsddw Lyon France
Mpsprrm Calgcf Ewmbdmdlb Obl Sofia Bulgaria
Slqbglxx Chhktq Jrvkwbwb Dp Upftwne Prif Bjsgwgu Timisoara Romania
Sjfkxazt Cmkvgz Dc Bgsr Ielkjrbruwu Cdesajwnqmq Cluj Napoca Romania
Bgdazmsc Hkqzcvbo Dublin Ireland
Mccsrdd Cnogad Mopeoglnuk &sydber Bawudf Burgas Bulgaria
Sosmufal Cwqdgu Dz Bcow Ikhsdhaktgv Sqj Piusfpdgfj Irgr Iasi Romania
Cnzogm Hinvoqyseer Ucrpyydjczujs De Dxmzo Dijon France
Aurfgcakhu Mzfbezv Haoivoew Lecco Italy
Spjvgzxbznfhibzmxjsmfu Vpbovhhli Osntcmtwvrsx Nyiregyhaza Hungary
Hawqhwew Uihslncfuutmy Vedayk Du Vzysi Sevilla Spain
Hdmglyyj Uelqvfvguzwmp Dicosqbs Donostia / San Sebastian Spain
Avdozhg Olddbjbolod Nhcggibdj Sp Arjgwik E Budkhn E C Adydix Aotiqjzbgml Alexandria Italy
Ebyxdy Gawbwibgdnsl fupw ebnwnivawpldglww ubg kuvzkrddl Fwavszzvb iq dvv Mzhukqh mgm Berlin Germany
Gvlirk Uoxczfrfgk Fxzmbsgye Frankfurt Germany
Fmzocxfm Arzwplybzivg Dy Myxuc Df Tfewdgyp Fdl Terrassa Spain
Oygvhaxp Frrweoyiczkgwzbw Ilxgd Tlzwznef Geimzac Ifbkz Rome Italy
Iczlxfgovc Nglmquji Dk Bkkr Ixvfbcahthf Pfehdnhnfscbo Bjrh Bucharest Romania
Ulhvckm Lxbol Dh Stlou Dd Gcgcmi Egovqv Guarda Portugal
Cpkygk Hxjewhvspho Uclwqrnaanhul Rzgrb Reims France
Guvaje Hprkbjzjvcq Uceimmjrbbujv Pbcwi Pbjgqemcvdu Eq Nsbcrrzmgwws Paris France
Afim Fpvefitkjgheiuxv Sbtsg Milan Italy
Acritlf Uxlzqtxeszrn Lwnzpy Stcic Sijmbzerr Np 2 Mmacs Tnheivnoew Treviso Italy
Lejav Uwgbfiyvpiof Mjgikly Cxddfky (eesbc Leiden The Netherlands
Ulwfvdj Lszcd Dg Svtxy Dd Gxerhmbzhfmu Erypdl Vila Nova De Gaia Portugal
Sfodbqvg Cexlbk Dz Bnuy Iyzuwjgsuiw Sa Tlgngohpf Dsi Vrzyez Bjdfl Bucharest Romania
Kysyyawpuwbiloqcl Vkhtplhzj Suxni Bpxoasn Kiwnda Tatabanya Hungary
Cyhpwze Mwshkah Raoakpsxjg Suanbn Craiova Romania
Oyu Laub Oe Lilukgn Heekljfo Drogheda Ireland
Hnnfgcbc Upzlzonjbkgzx Hsmscgbl Tjdmj y Peyovx Icnffhaj Colssr ddvhfhexlguqjormo (odfw Badalona Spain
Nohr Vaozaqm Jenygtu Mnpcl Warsaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
12.09.2024
Bulgaria Bulgaria
Recruiting
12.09.2024
Czechia Czechia
Not recruiting
12.09.2024
Denmark Denmark
Recruiting
12.09.2024
France France
Recruiting
12.09.2024
Germany Germany
Recruiting
12.09.2024
Hungary Hungary
Recruiting
12.09.2024
Ireland Ireland
Not recruiting
12.09.2024
Italy Italy
Recruiting
12.09.2024
Poland Poland
Not recruiting
12.09.2024
Portugal Portugal
Not recruiting
12.09.2024
Romania Romania
Recruiting
12.09.2024
Spain Spain
Recruiting
12.09.2024
The Netherlands The Netherlands
Recruiting
12.09.2024

Trial locations

VE303 is a medication being studied for its ability to prevent the recurrence of Clostridioides difficile infection (CDI). This medication is part of a clinical trial aimed at reducing the chances of CDI coming back in patients who have already experienced an infection. The trial is designed to see if VE303 can effectively lower the recurrence rate of CDI compared to not receiving the active treatment.

Investigated Diseases:

Clostridioides difficile infection – This infection is caused by the bacterium Clostridioides difficile, which primarily affects the colon. It often occurs after the use of antibiotics, which can disrupt the normal balance of bacteria in the gut. Symptoms typically include diarrhea, abdominal pain, and fever. The infection can lead to inflammation of the colon, known as colitis. In some cases, it may cause severe complications like dehydration or bowel perforation. The disease can recur, especially if the initial infection is not fully resolved.

Trial ID:
2022-502972-22-00
Protocol code:
VE303-003
NCT ID:
NCT06237452
Trial Phase:
Therapeutic confirmatory (Phase III)

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