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;
ABResearch S.r.l.
Lead sponsor
Nextrasearch S.r.l.s.
Collaborator