Status: Recruiting

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).

Participants needed: 852

Trial details

Phase: Phase 3Age: 12+Biological sex: AllType: InterventionalSponsor: Vedanta Biosciences, Inc.Updated: Jun 2, 2026Locations: 215

Eligibility criteria

Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a labora... [+15]

History of chronic diarrhea (defined as ≥ 3 loose stools per day lasting for at... [+7]

Status: Not yet recruiting

Evaluation of Gut Microbiota and Its Associated Resistome in FMT Donors and Recipients Due to Recurrent Clostridiodes Difficile Infection

Caratterizzazione della composizione microbica intestinale nei donatori di FMT e nei pazienti affetti da rCDI al tempo basale e a seguito del trapianto di microbiota fecale. Negli stessi time point valutare il resistoma associato alla comunità microbica rilevata.

Participants needed: 24

Trial details

Age: 18+Biological sex: AllType: ObservationalSponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCSUpdated: Aug 1, 2024

Eligibility criteria

patients with rCDI (> 18 years) to whom faecal microbiota transplantation is ind... [+2]

antibiotic therapies in the last 30 days [+6]