NCT06839209 Advantages and Disadvantages of TOXCLEAN As Add on Treatment to SOC in Patients with Clostridium Difficile-associated Diarrhea
| NCT ID | NCT06839209 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ABResearch S.r.l. |
| Condition | Clostridium; Difficile, As Cause of Disease Classified Elsewhere |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 18 participants in total. It began in 2025-01-27 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Giovanni Cammarota, Professor
PRINCIPAL INVESTIGATOR
Direttore U.O.C. GASTROENTEROLOGIA Policlinico Gemelli
Frequently Asked Questions
Who can join the NCT06839209 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Clostridium; Difficile, As Cause of Disease Classified Elsewhere. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06839209 currently recruiting?
Yes, NCT06839209 is actively recruiting participants. Contact the research team at giovanni.cammarota@policlinicogemelli.it for enrollment information.
Where is the NCT06839209 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06839209 clinical trial?
NCT06839209 is sponsored by ABResearch S.r.l.. The principal investigator is Giovanni Cammarota, Professor at Direttore U.O.C. GASTROENTEROLOGIA Policlinico Gemelli. The trial plans to enroll 18 participants.