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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Clostridium Difficile Diarrhea; Clostridium; Difficile, As Cause of Disease Classified Elsewhere
• Intervention / Treatment: Device: Toxclean 1g

Detailed Description

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. Primary

• Percentage of patients that complete Toxclean schedule treatment; Secondary
• Safety and tolerability of two different dosage of oral Toxclean treatment;
• Reduction of toxin amount in fecal sample;
• Clinical response after 28-day oral administration of two different dosage of TOXCLEAN in combination with SoC therapy;
• CDAD symptoms improvements during treatment and follow up periods;
• Fecal concentration of Toxclean;

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giovanni Cammarota, Professor; Phone Number: +39 0630154732; Email: giovanni.cammarota@policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • Policlinico Gemelli
    • Contact: Giovanni Cammarota, Professor; Email: giovanni.cammarota@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single dosage; 1 g of Toxclean once a day for 28 days plus SoC therapy	Device: Toxclean 1g; 1 g of Toxclean once or twice daily for 28 days
Experimental: Double dosage; 1 g of Toxclean twice daily for 28 days plus SoC therapy	Device: Toxclean 1g; 1 g of Toxclean once or twice daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the assessment of the safety and tolerability of two different dosage of oral Toxclean treatment	Safety and tolerability of two dosage of oral Toxclean powder plus SoC assessed by number of participants who experienced adverse events	28 days
the clinical response after 14-day oral administration of two different dosage of TOXCLEAN in combination with SoC therapy;	time to resolution of diarrhea: time in days from start of treatment to the first formed bowel movement	14 days
the CDAD symptoms improvements during treatment and follow up periods	reduction of CDAD symptoms such as abdominal pain, nausea etc	2 months
Measurement of Toxclean fecal concentration of Toxclean	C. difficile toxins in fecal sample;	28 days

Collaborators and Investigators

• Sponsor: ABResearch S.r.l.
• Collaborators: Nextrasearch S.r.l.s.
• Investigators: Principal Investigator: Giovanni Cammarota, Professor, Direttore U.O.C. GASTROENTEROLOGIA Policlinico Gemelli

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: clostridium difficile; clostridium; cdad
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Clostridium Infections; Diarrhea
• Other Study ID Numbers: TOXCCAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study report published
• IPD Sharing Time Frame: After Study conclusion, no time limits
• IPD Sharing Access Criteria: Published on Peer journals
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No