Clostridium; Difficile, As Cause of Disease Classified ElsewhereNCT06839209
Advantages and Disadvantages of TOXCLEAN As Add on Treatment to SOC in Patients with Clostridium Difficile-associated Diarrhea
A study testing Toxclean 1g in people with Clostridium; Difficile, As Cause of Disease Classified Elsewhere and Clostridium Difficile Diarrhea, run by ABResearch S.r.l. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium; Difficile, As Cause of Disease Classified Elsewhere, Clostridium Difficile Diarrhea
- What is being tested?
- Toxclean 1g
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jan 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Gemelli
Roma, 00168
Giovanni Cammarota, Professor, giovanni.cammarota@policlinicogemelli.it
About this study
Official title: 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.
Read the 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;
- Conditions
- Clostridium; Difficile, As Cause of Disease Classified Elsewhere, Clostridium Difficile Diarrhea
- Being tested
- Toxclean 1g
- Keywords
- clostridium difficile, clostridium, cdad
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toxclean 1gDevice
1 g of Toxclean once or twice daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Single dosage | Experimental | 1 g of Toxclean once a day for 28 days plus SoC therapy Receives: Device: Toxclean 1g |
| Double dosage | Experimental | 1 g of Toxclean twice daily for 28 days plus SoC therapy Receives: Device: Toxclean 1g |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (4)
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
Measured: 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
Measured: 14 days
the CDAD symptoms improvements during treatment and follow up periods
reduction of CDAD symptoms such as abdominal pain, nausea etc
Measured: 2 months
Measurement of Toxclean fecal concentration of Toxclean
- difficile toxins in fecal sample;
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start27 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium; Difficile, As Cause of Disease Classified ElsewhereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ABResearch S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nextrasearch S.r.l.s.
- Responsible party
- Sponsor
- Investigators
- Giovanni Cammarota, Professor, Principal investigator, Direttore U.O.C. GASTROENTEROLOGIA Policlinico Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839209
- Sponsor's protocol ID
- TOXCCAD
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study report published
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Advantages and Disadvantages of TOXCLEAN As Add on Treatment to SOC in Patients with Clostridium Difficile-associated Diarrhea
- ClinicalTrials.gov ID
- NCT06839209
- Acronym / sponsor ID
- TOXCCAD
- Conditions
- Clostridium; Difficile, As Cause of Disease Classified Elsewhere, Clostridium Difficile Diarrhea
- Keywords
- clostridium difficile, clostridium, cdad
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- ABResearch S.r.l.Industry (pharma, biotech, devices)
- Collaborators
- Nextrasearch S.r.l.s.
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Single dosage | Experimental | Device: Toxclean 1g1 g of Toxclean once a day for 28 days plus SoC therapy |
| Double dosage | Experimental | Device: Toxclean 1g1 g of Toxclean twice daily for 28 days plus SoC therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toxclean 1g1 g of Toxclean once or twice daily for 28 days | Device | Double dosage, Single dosage |
Primary outcome
Percentage of patients that complete Toxclean schedule treatment
Time frame: 28 days
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
4 secondary outcomes
the assessment of the safety and tolerability of two different dosage of oral Toxclean treatment
Time frame: 28 days
the clinical response after 14-day oral administration of two different dosage of TOXCLEAN in combination with SoC therapy;
Time frame: 14 days
the CDAD symptoms improvements during treatment and follow up periods
Time frame: 2 months
Measurement of Toxclean fecal concentration of Toxclean
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: Yes. Study report published
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giovanni Cammarota, Professor principal investigator
Direttore U.O.C. GASTROENTEROLOGIA Policlinico Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toxclean 1g in people with Clostridium; Difficile, As Cause of Disease Classified Elsewhere and Clostridium Difficile Diarrhea, run by ABResearch S.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Cammarota, Professor (+39 0630154732, giovanni.cammarota@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients that complete Toxclean schedule treatment (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.