Evaluating Toxclean as an additional treatment for recurrent Clostridium difficile diarrhea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Policlinico Gemelli
  Roma, Italy Recruiting

Study contacts

• Principal investigator: Giovanni Cammarota, Professor — Direttore U.O.C. GASTROENTEROLOGIA Policlinico Gemelli
• Study coordinator: Giovanni Cammarota, Professor
• Email: giovanni.cammarota@policlinicogemelli.it
• Phone: +39 0630154732

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Botulinum toxin injection for thumb arthritis pain

  This study is testing if botulinum toxin injections can help relieve thumb arthritis pain for people who haven't found relief with other treatments.

  Recruiting Phase 3 Rhode Island Hospital · Providence, Rhode Island · NCT05990881

• Using alanyl-glutamine to treat C. difficile infections

  This study is testing if taking alanyl-glutamine can help people with C. difficile infections recover better and prevent the infection from coming back.

  Recruiting at 2 sites Phase 2 University of Virginia · Charlottesville, Virginia and 1 other locations · NCT04305769

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.