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NCT06839209

Advantages and Disadvantages of TOXCLEAN As Add on Treatment to SOC in Patients with Clostridium Difficile-associated Diarrhea

Recruiting now NA Last updated 26 February 2025
What this trial tests

NA trial testing Toxclean 1g in Clostridium; Difficile, As Cause of Disease Classified Elsewhere in 18 participants. Currently enrolling.

Timeline
27 January 2025
Primary endpoint
31 December 2025
31 December 2025

Quick facts

Lead sponsorABResearch S.r.l.
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment18
Start date27 January 2025
Primary completion31 December 2025
Estimated completion31 December 2025
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

ABResearch S.r.l.

Who can join

18 and older, any sex, with Clostridium; Difficile, As Cause of Disease Classified Elsewhere or Clostridium Difficile Diarrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single center, randomized, exploratory clinical investigation that will evaluate the safety and efficacy of Toxclean (ABResearch srl) as add on treatment to Standard therapy in 24 patients with recurrent CDAD. Eligible subjects will be adult patients with recurrent CDAD. Recurrent CDAD, for the purpose of this protocol, is defined as one or more new episode of diarrhea (Ned) within two months from the end of the SoC treatment. The objective of this pilot study is to evaluate whether 1 or 2 grams of Toxclean powder is orally administrable and well tolerated as add on treatment to SoC in patients with recurrent CDAD.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06839209.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing