Actively Recruiting
Advantages and Disadvantages of TOXCLEAN As Add on Treatment to SOC in Patients with Clostridium Difficile-associated Diarrhea
Led by ABResearch S.r.l. · Updated on 2025-02-26
18
Participants Needed
1
Research Sites
48 weeks
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
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.
CONDITIONS
Official 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 26 18 years, male or female, at the time of informed consent
- Signed informed consent by patient or legally authorized representative
- Diagnosis of recurrent CDAD, defined as one or more new episodes of diarrhea occurring 2-8 weeks after symptom resolution or negative fecal test
- Detection of C. difficile toxins by NAAT, EIA, or GDH
- Received at least one adequate antibiotic therapy course for CDAD (26 10 days of vancomycin 26 125 mg four times daily, metronidazole 500 mg three times daily, or fidaxomicin 200 mg twice daily for 10 days)
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 diarrhea of unknown cause since initial CDAD episode
- Use of oral anticoagulant medications including warfarin and NOACs
- 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
- Current use of Bezlotuxamab/Zinplava
- Pregnancy or lactation
- Known hypersensitivity to Toxclean or its ingredients
AI-Screening
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Trial Site Locations
Total: 1 location
1
Policlinico Gemelli
Roma, Italy, 00168
Actively Recruiting
Research Team
G
Giovanni Cammarota, Professor
CONTACT
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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