NCT06839209

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: ABResearch S.r.l. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. Primary * Percentage of patients that complete Toxclean schedule treatment; Secondary * Safety and tolerability of two different dosage of oral Toxclean treatment; * Reduction of toxin amount in fecal sample; * Clinical response after 28-day oral administration of two different dosage of TOXCLEAN in combination with SoC therapy; * CDAD symptoms improvements during treatment and follow up periods; * Fecal concentration of Toxclean;

Conditions

• Clostridium; Difficile, As Cause of Disease Classified Elsewhere
• Clostridium Difficile Diarrhea

Interventions

Type	Name	Description
DEVICE	Toxclean 1g	1 g of Toxclean once or twice daily for 28 days

Timeline

• Start date: 2025-01-27
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-02-21
• Last updated: 2025-02-26

Locations

1 site across 1 country: Italy