Evaluating Toxclean as an additional treatment for recurrent Clostridium difficile diarrhea

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

This study is testing if adding a new oral treatment called Toxclean can help adults with recurring Clostridium difficile diarrhea feel better when used alongside their regular treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ABResearch S.r.l. (Industry-sponsored)
• Drugs / interventions: Bezlotuxamab
• Locations: 1 site (Roma)
• Trial ID: NCT06839209 on ClinicalTrials.gov

What this trial studies

This clinical investigation focuses on the safety and efficacy of Toxclean, an oral treatment, when added to standard therapy for patients suffering from recurrent Clostridium difficile-associated diarrhea (CDAD). The study will enroll 24 adult patients who have experienced new episodes of diarrhea within two months after standard treatment. Participants will receive either 1 or 2 grams of Toxclean powder, and the study will assess treatment completion rates, safety, tolerability, and clinical response over a 28-day period. The primary goal is to determine if Toxclean can effectively reduce symptoms and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of recurrent CDAD who have previously received adequate antibiotic therapy.

Not a fit: Patients with a history of inflammatory bowel disease or bowel resection surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients suffering from recurrent CDAD, potentially improving their quality of life.

How similar studies have performed: While this approach is exploratory, similar studies evaluating adjunctive treatments for recurrent CDAD have shown promise, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* 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;
* Received at least one course of adequate antibiotic therapy for CDAD (≥ 10 days of vancomycin at a dose of ≥125 mg four times per day, ≥ 10 days of metronidazole at a dose 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 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;
* Clinically immunocompromised due to any primary immune or autoimmune deficiency, as a result of chronic disease, cancer or medication used to treat these diseases
* Consumption of the following prescription medications during the current enrollment episode: Bezlotuxamab/Zinplava Is pregnant or lactating Known hypersensitivity to the active principle or excipients

Where this trial is running

Roma

• Policlinico Gemelli — Roma, Italy (Recruiting)

Study contacts

• Principal investigator: Giovanni Cammarota, Professor — Direttore U.O.C. GASTROENTEROLOGIA Policlinico Gemelli
• Study coordinator: Giovanni Cammarota, Professor

Conditions Clostridium; Difficile, As Cause of Disease Classified Elsewhere; Clostridium Difficile Diarrhea; clostridium difficile; clostridium; cdad