RecruitingNot ApplicableNCT06839209

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

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


Sponsor

ABResearch S.r.l.

Enrollment

18 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Toxclean 1g for people with clostridium difficile diarrhea and clostridium; difficile, as cause of disease classified elsewhere. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEToxclean 1g

1 g of Toxclean once or twice daily for 28 days


Locations(1)

Policlinico Gemelli

Roma, Italy

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NCT06839209


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