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.
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;
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
18
1 g of Toxclean once or twice daily for 28 days
Policlinico Gemelli
Roma, Italy
RECRUITINGPercentage of patients that complete Toxclean schedule treatment
The primary objective of this early feasibility clinical 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 recurrent
Time frame: 28 days
the assessment of the safety and tolerability of two different dosage of oral Toxclean treatment
Safety and tolerability of two dosage of oral Toxclean powder plus SoC assessed by number of participants who experienced adverse events
Time frame: 28 days
the clinical response after 14-day oral administration of two different dosage of TOXCLEAN in combination with SoC therapy;
time to resolution of diarrhea: time in days from start of treatment to the first formed bowel movement
Time frame: 14 days
the CDAD symptoms improvements during treatment and follow up periods
reduction of CDAD symptoms such as abdominal pain, nausea etc
Time frame: 2 months
Measurement of Toxclean fecal concentration of Toxclean
C. difficile toxins in fecal sample;
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.