NCT04891965

A Study of ART24 in Subjects Recently Cured of a Clostridioides Difficile Infection (CDI)

Completed Phase 1 Last updated 17 October 2022

What this trial tests

Phase 1 trial testing ART24 in Clostridium Difficile Infection Recurrence in 36 participants. Completed in 13 October 2022.

Timeline

27 February 2020

Primary endpoint
7 July 2022

13 October 2022

Quick facts

Lead sponsor	Adiso Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	36
Start date	27 February 2020
Primary completion	7 July 2022
Estimated completion	13 October 2022
Sites	15 locations across Canada, United States

Drugs / interventions tested

• ART24 — full drug profile →
• Placebo

Conditions studied

• Clostridium Difficile Infection Recurrence — all drugs for Clostridium Difficile Infection Recurrence →

Sponsor

Adiso Therapeutics — full company profile →

Who can join

18 and older, any sex, with Clostridium Difficile Infection Recurrence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized, placebo-controlled, double-blind, multi-site study in which up to approximately 36 subjects with a recent C. difficile infection (CDI) who have completed a standard of care course of CDI antibiotics and have achieved clinical cure based on signs and symptoms, will be randomized to 7 or 28 daily doses of ART24 or placebo. Subjects will be followed for 6 months after the last dose of study drug.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Urgent Threat of <i>Clostridioides difficile</i> Infection: A Glimpse of the Drugs of the Future, with Related Patents and Prospects.
   Alshrari AS, Hudu SA, Elmigdadi F, Imran M. · · 2023 · cited 17× · PMID 36830964 · DOI 10.3390/biomedicines11020426
2. The regulatory framework for microbiome-based therapies: insights into European regulatory developments.
   Rodriguez J, Cordaillat-Simmons M, Pot B, Druart C. · · 2025 · cited 13× · PMID 40155609 · DOI 10.1038/s41522-025-00683-0
3. Microbiota-Based Live Biotherapeutic Products for <i>Clostridioides Difficile</i> Infection- The Devil is in the Details.
   Monday L, Tillotson G, Chopra T. · · 2024 · cited 9× · PMID 38375101 · DOI 10.2147/idr.s419243
4. <i>Clostridioides difficile</i> infection: microbe-microbe interactions and live biotherapeutics.
   Wang R. · · 2023 · cited 8× · PMID 37228365 · DOI 10.3389/fmicb.2023.1182612
5. Bacterial live therapeutics for human diseases.
   Frutos-Grilo E, Ana Y, Gonzalez-de Miguel J, Cardona-I-Collado M, et al · · 2024 · cited 6× · PMID 39443745 · DOI 10.1038/s44320-024-00067-0
6. What's New and What's Next in Fecal Microbiota Transplantation?
   Baydoun H, Hussain N, Wu KO, Kelly CR, et al · · 2025 · PMID 40861872 · DOI 10.2147/btt.s486372
7. LPAR3: a shared target for neurodegenerative diseases?
   Acton S, Chesnel L. · · 2025 · PMID 39665827 · DOI 10.4103/nrr.nrr-d-24-01024