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

Inclusion Criteria:

• Age ≥ 18 years, male or female, at the time of informed consent

• Signed informed consent by patient, or where applicable, patient's legallyauthorized representative;

• Diagnosis of recurrent CDAD, defined as those episodes of C. Difficile associateddiarrhea occurring 2-8 weeks after either the symptoms resolution of a previous CDADepisode or C. difficile negativization of fecal sample.

• Detection of C. difficile toxins by nucleic acid amplification tests (NAAT), EIA orGDH;

• Received at least one course of adequate antibiotic therapy for CDAD (≥ 10 days ofvancomycin at a dose of ≥125 mg four times per day, ≥ 10 days of metronidazole at adose of 500mg three times per day or fidaxomixin 200mg twice a day for 10 days)

Exclusion Criteria:

• History of C. difficile complicating inflammatory bowel disease (Crohn's disease,ulcerative colitis), or history of bowel resection surgery (other than uncomplicatedappendectomy) or history of other infectious diarrhea or diarrhea of unknownetiology since the initial episode of CDAD;

• Participants who require oral anticoagulant medications, including but not limitedto warfarin and NOACs (novel oral anticoagulants);

• Major gastrointestinal surgery within 3 months of enrollment;

• History of swallowing difficulties, including dysphagia or odynophagia for liquidsor solids;

• Clinically immunocompromised due to any primary immune or autoimmune deficiency, asa result of chronic disease, cancer or medication used to treat these diseases

• Consumption of the following prescription medications during the current enrollmentepisode: Bezlotuxamab/Zinplava Is pregnant or lactating Known hypersensitivity tothe active principle or excipients