Pilot Study Evaluating Toxclean as an Add-on to Standard Therapy for Adults with Recurrent Clostridium Difficile-associated Diarrhea

What this Trial Is About

Researchers are investigating the safety and effectiveness of adding Toxclean, a powder developed by ABResearch srl, to standard therapy for adults with recurrent Clostridium Difficile-associated diarrhea CDAD. This exploratory, randomized study focuses on patients who have experienced a new episode of diarrhea within two months after completing standard CDAD treatment, aiming to see if 1 or 2 grams of Toxclean can be taken orally and tolerated well alongside standard care. Participants will be randomly assigned to one of two groups one receiving 1 gram of Toxclean once daily for 28 days plus standard therapy, and the other receiving 1 gram twice daily for 28 days plus standard therapy. The study will assess the completion rate of Toxclean treatment, safety, tolerability, clinical response after 14 and 28 days, symptom improvements during and after treatment, and fecal Toxclean concentration. During the study, participants will be monitored through clinical assessments, fecal toxin measurements, and symptom tracking over a 28-day treatment period and follow-up lasting two months. Researchers will evaluate safety, tolerance, and effectiveness of Toxclean combined with standard therapy. The total study duration includes treatment and follow-up, with participant progress closely observed by the study team.

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