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.
Age ≥ 18 years, male or female, at the time of informed consent
Signed informed consent by patient, or where applicable, patient's legally authorized representative;
Diagnosis of recurrent CDAD, defined as those episodes of C. Difficile associated diarrhea occurring 2-8 weeks after either the symptoms resolution of a previous CDAD episode or C. difficile negativization of fecal sample.
Detection of C. difficile toxins by nucleic acid amplification tests (NAAT), EIA or GDH;
History of C. difficile complicating inflammatory bowel disease (Crohn's disease, ulcerative colitis), or history of bowel resection surgery (other than uncomplicated appendectomy) or history of other infectious diarrhea or diarrhea of unknown etiology since the initial episode of CDAD;
Participants who require oral anticoagulant medications, including but not limited to warfarin and NOACs (novel oral anticoagulants);
Major gastrointestinal surgery within 3 months of enrollment;
History of swallowing difficulties, including dysphagia or odynophagia for liquids or solids;
Parallel
Toxclean 1g
Device1 g of Toxclean once or twice daily for 28 days
Percentage 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
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
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
the CDAD symptoms improvements during treatment and follow up periods
reduction of CDAD symptoms such as abdominal pain, nausea etc
Measurement of Toxclean fecal concentration of Toxclean
C. difficile toxins in fecal sample;
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ABResearch S.r.l.
Lead sponsor
Nextrasearch S.r.l.s.
Collaborator
