An interventional study of Toxclean 1g in Clostridium; Difficile, As Cause of Disease Classified Elsewhere and Clostridium Difficile Diarrhea, sponsored by ABResearch S.r.l.. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by ABResearch S.r.l. · Not applicable, Interventional, and Supportive care
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Among 26 studies in Diarrhea with a site in Italy — 4 open to participants now, 4 under way, none of them phase 3. Diarrhea · Italy.
Among the 26 studies in Diarrhea with a site in Italy, this one is the 21st largest by planned enrollment of the 22 interventional ones that give a count, is one of 2 that started in 2025, is one of 15 with no phase, and was the 23rd registered.
878 studies on the registry are indexed under Diarrhea; 77 are open to participants now.
Browse Diarrhea studies →4 of the 26 studies in Diarrhea with a site in Italy are open now. Recruiting first, the newest first:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Sites in Italy
Ages 3 mo–24 mo
University of Padova · Sites in Italy
Ages 18–80
Liaquat University of Medical & Health Sciences · Sites in Italy
Ages 0–12
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 45 Diarrhea studies recruiting now, 21 (47%) set no upper age limit and 22 (49%) stop at 75 or younger; 19 take children under 18; 15 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 3 · Phase 4 2
First in 2006; this study’s year is marked. 2 started in 2025.
This study's planned enrollment of 18 is below the median of 138 across 739 interventional studies indexed under Diarrhea.
Median enrollment 117 across the 22 interventional studies, 71 across the 4 observational. Of the 19 that completed or were terminated, 2 (11%) have results posted.
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10 of 26 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with ABResearch S.r.l. as lead sponsor.
ABResearch S.r.l. has 1 study filed under Diarrhea — fewer than ten, so there is no comparison to draw.
1 of the studies in Diarrhea with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07936656Liaquat University of Medical & Health SciencesProbiotic Bifidobacterium Breve PRL2020 in Oral Drops in Preventing Side Effects From Amoxicillin or Amoxicillin/Clavulanic Acid Antibiotic Use | 2027-03-01 |
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Among the 26 studies in Diarrhea with a site in Italy, from their registry updates:
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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.
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
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1 g of Toxclean once a day for 28 days plus SoC therapy
Device: Toxclean 1g
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
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
Time frame: 28 days
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
Time frame: 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
Time frame: 14 days
the CDAD symptoms improvements during treatment and follow up periods
reduction of CDAD symptoms such as abdominal pain, nausea etc
Time frame: 2 months
Measurement of Toxclean fecal concentration of Toxclean
C. difficile toxins in fecal sample;
Time frame: 28 days
Plan to share: Yes — Study report published
Supporting information: Clinical study report
Time frame: After Study conclusion, no time limits
Access criteria: Published on Peer journals
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2025, 11 months after the start.
Of 35 industry-sponsored interventional studies with no phase under Diarrhea, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 23. This study's planned 11 months is close to that.
Counting every sponsor, half of 164 studies reached it within 14 months; a quarter within 5 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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