Actively Recruiting
Pilot Study Evaluating Toxclean as Add-on Treatment to Standard Therapy for Recurrent Clostridium Difficile-associated Diarrhea
Led by ABResearch S.r.l. · Updated on 2025-02-26
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
ABResearch S.r.l.
Lead Sponsor
N
Nextrasearch S.r.l.s.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of adding Toxclean, a powder developed by ABResearch srl, to standard therapy for adults with recurrent Clostridium Difficile-associated diarrhea (CDAD). This exploratory, randomized study focuses on patients who have experienced a new episode of diarrhea within two months after completing standard CDAD treatment, aiming to see if 1 or 2 grams of Toxclean can be taken orally and tolerated well alongside standard care. Participants will be randomly assigned to one of two groups: one receiving 1 gram of Toxclean once daily for 28 days plus standard therapy, and the other receiving 1 gram twice daily for 28 days plus standard therapy. The study will assess the completion rate of Toxclean treatment, safety, tolerability, clinical response after 14 and 28 days, symptom improvements during and after treatment, and fecal Toxclean concentration. During the study, participants will be monitored through clinical assessments, fecal toxin measurements, and symptom tracking over a 28-day treatment period and follow-up lasting two months. Researchers will evaluate safety, tolerance, and effectiveness of Toxclean combined with standard therapy. The total study duration includes treatment and follow-up, with participant progress closely observed by the study team.
CONDITIONS
Brief Title
Advantages and Disadvantages of TOXCLEAN As Add on Treatment to SOC in Patients with Clostridium Difficile-associated Diarrhea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender, at the time of informed consent
- Signed informed consent by patient or legally authorized representative
- Diagnosis of recurrent Clostridium Difficile-associated diarrhea occurring 2-8 weeks after prior episode resolution
- Detection of C. difficile toxins by nucleic acid amplification tests, EIA, or GDH
- Received at least one adequate antibiotic therapy course for CDAD (minimum 10 days of vancomycin, metronidazole, or fidaxomicin)
You will not qualify if you...
- History of C. difficile complicating inflammatory bowel disease or bowel resection surgery other than uncomplicated appendectomy
- History of other infectious diarrhea or unknown cause diarrhea since initial CDAD episode
- Use of oral anticoagulant medications including warfarin or novel oral anticoagulants
- Major gastrointestinal surgery within 3 months before enrollment
- History of swallowing difficulties such as dysphagia or odynophagia
- Clinically immunocompromised due to immune deficiency, chronic disease, cancer, or related medications
- Use of Bezlotuxamab/Zinplava during current enrollment episode
- Pregnant or lactating individuals
- Known hypersensitivity to active ingredient or excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants receive Toxclean powder as an add-on to standard therapy for recurrent Clostridium Difficile-associated diarrhea. They take either 1 g once daily or 1 g twice daily for 28 days.
Weekly visits for up to 4 weeks
Duration - Up to 2 months
Participants are monitored for symptom improvements and safety following the treatment period.
1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
Policlinico Gemelli
Roma, Italy, 00168
Actively Recruiting
Research Team
G
Giovanni Cammarota, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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