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

NCT06839209 | Recruiting

• 1 other identifier: TOXCCAD
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridium; Difficile, As Cause of Disease Classified Elsewhere; Clostridium Difficile Diarrhea

Keywords

clostridium difficile; clostridium; cdad

Outcome Measures

Primary Outcomes (1)

• Percentage of patients that complete Toxclean schedule treatment

  The primary objective of this early feasibility clinical 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 recurrent

  28 days

Secondary Outcomes (4)

• the assessment of the safety and tolerability of two different dosage of oral Toxclean treatment

  28 days

• the clinical response after 14-day oral administration of two different dosage of TOXCLEAN in combination with SoC therapy;

  14 days

• the CDAD symptoms improvements during treatment and follow up periods

  2 months

• Measurement of Toxclean fecal concentration of Toxclean

  28 days

Study Arms (2)

Single dosage

EXPERIMENTAL

1 g of Toxclean once a day for 28 days plus SoC therapy

Device: Toxclean 1g

Double dosage

EXPERIMENTAL

1 g of Toxclean twice daily for 28 days plus SoC therapy

Device: Toxclean 1g

Interventions

Toxclean 1g DEVICE

1 g of Toxclean once or twice daily for 28 days

Double dosage; Single dosage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• ABResearch S.r.l.: lead
• Nextrasearch S.r.l.s.: collaborator

Study Sites (1)

Policlinico Gemelli

Roma, 00168, Italy

RECRUITING

Study Officials

• Giovanni Cammarota, Professor

  Direttore U.O.C. GASTROENTEROLOGIA Policlinico Gemelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Cammarota, Professor

CONTACT

+39 0630154732; giovanni.cammarota@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cohort A: 1 g of Toxclean once a day for 28 days plus SoC therapy Cohort B: 1 g of Toxclean twice daily for 28 days plus SoC therapy

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: January 27, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: After Study conclusion, no time limits
• Access Criteria: Published on Peer journals

Locations

IT (1)