Crohn Disease (CD)Phase 1/2AUTOCDNCT07263880
Clostridium Butyricum in Stenosing Crohn's Disease
A Phase 1/2 study testing Clostridum Butyricum Capsule and Trehalose in people with Crohn Disease (CD), run by San Giovanni Addolorata Hospital at 1 site in Italy.
Trial summary
Crohn's disease is a condition of unknown etiology with an immune-mediated pathogenesis. The subgroup of Crohn's disease with a stricturing phenotype represents a particular challenge for clinicians, as currently no effective medical therapies are available for the prevention or treatment of fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Crohn Disease (CD)
- What is being tested?
- Clostridum Butyricum Capsule and Trehalose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 8 May 2026to 1 Feb 2027
- Phase
- Phase 1/2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients with a confirmed diagnosis of Crohn's disease (established according to clinical, endoscopic, histological, and radiological criteria in line with current Italian and European guidelines), with a stricturing phenotype (B2 according to the Montreal classification), determined based on the patient's clinical history and instrumental examinations, with disease localized to the right colon or ileocecal region, followed at the Inflammatory Bowel Disease Outpatient Clinic of the Gastroenterology and Digestive Endoscopy Unit, in whom a colonoscopy with biopsies has been scheduled for clinical indication (disease reassessment, flare-up, or follow-up).
- Patients aged ≥18 and ≤85 years.
- Patients either not receiving any specific immunomodulatory therapy for Crohn's disease or undergoing treatment with mesalazine or sulfasalazine.
- Patients who have been adequately informed about the study protocol and who have understood and voluntarily signed the informed consent form.
Who cannot join
- Other acute or chronic inflammatory bowel diseases (e.g., diverticulitis, infectious colitis, ulcerative colitis).
- Patients receiving treatment for Crohn's disease with immunosuppressive drugs (thiopurines, methotrexate, cyclosporine), biologics (anti-TNFα, vedolizumab, ustekinumab), oral antiJAK or oral/intravenous corticosteroids.
- Immunological or rheumatologic diseases.
- Current or past malignancies.
- Active infections.
- History of organ transplantation.
- Current treatments with pharmacological agents known to significantly modulate the autophagic process.
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
San Giovanni Addolorata Hospital
Roma, 00184
Cristiano Pagnini, MD, PhD, +39 06 7705 1, cpagnini@gmail.com
About this study
Official title: Efficacy and Safety of Therapeutic Application of Clostridium Butyricum in Patiens With Stenosing Crohn's Disease: a Pilot Study
Crohn's disease is a condition of unknown etiology with an immune-mediated pathogenesis. The subgroup of Crohn's disease with a stricturing phenotype represents a particular challenge for clinicians, as currently no effective medical therapies are available for the prevention or treatment of fibrosis. Autophagy is a key mechanism in the regulation of cellular homeostasis, and preliminary reports from our group and others have suggested a potential role in the pathogenesis of fibrostenotic complications in Crohn's disease.
The next-generation probiotic Clostridium butyricum has recently been proposed as a treatment option in several conditions, including inflammatory bowel diseases (IBD). Its beneficial effects are mainly exerted through the production of butyric acid, which in turn plays important roles at the intestinal mucosal level, including the stimulation of autophagy. The possibility of stimulating autophagy in patients with stricturing Crohn's disease may represent a promising therapeutic approach for the prevention and treatment of fibrosis.
Read more
This study involves the collection of biopsy and blood samples from 40 patients with stricturing Crohn's disease undergoing colonoscopy. In the two months preceding colonoscopy, patients will be randomized into four groups:
Patients treated with C. butyricum
Patients treated with the autophagy stimulator trehalose
Patients treated with C. butyricum + trehalose
Patients treated with placebo
Laboratory analyses will be performed on biopsy and blood samples to evaluate and quantify molecular mediators involved in inflammation, fibrosis, and autophagy.
Read the detailed description
Crohn's disease is a chronic, relapsing inflammatory bowel disease with unknown etiology, involving immune dysregulation and microbiota alterations. Stricturing disease (Montreal B2 phenotype) represents a major unmet therapeutic need, as no pharmacological therapies are currently available for intestinal fibrosis, which is often managed surgically.
Autophagy, a key regulator of cellular homeostasis, has been linked to Crohn's disease pathogenesis, with genetic studies identifying polymorphisms in autophagy-related genes. Impaired autophagy may exacerbate inflammation, oxidative stress, and tissue damage. Preliminary data from our group show reduced autophagy in patients with stricturing Crohn's disease compared to those with inflammatory phenotype or healthy controls.
Clostridium butyricum, a next-generation probiotic with strong butyrate-producing activity, exerts anti-inflammatory and mucosal protective effects partly through stimulation of autophagy. Its use may represent a novel therapeutic approach to prevent or mitigate fibrostenotic complications in Crohn's disease.
This is a non-profit, interventional clinical pilot study enrolling 40 patients with stricturing Crohn's disease (B2, Montreal classification; localization L2 or L3). Patients undergoing clinically indicated colonoscopy will be randomized to one of four groups to receive for two months prior to the procedure:
- C. butyricum supplementation
- Trehalose supplementation (a known autophagy inducer)
- Combined C. butyricum + trehalose
- Placebo During colonoscopy, routine biopsies will be obtained, with two additional samples collected for research purposes, along with peripheral blood samples. Laboratory analyses will focus on molecular mediators of inflammation, fibrosis, oxidative stress, and autophagy pathways.
The primary objective is to test the hypothesis that C. butyricum is safe and capable of stimulating local autophagic processes in the intestinal mucosa of patients with stricturing Crohn's disease.
Secondary objectives include evaluating autophagy-related pathways (inflammation, fibrosis, ROS production, NADPH oxidase activity) and comparing outcomes across the four treatment groups. Laboratory procedures will be used to evaluate and quantify, in bioptic and blood samples autophagy, inflammation, fibrosis, and oxidative stress.In particular, autophagy will be evaluated by measurement of the mucosal autophagic markers LC3b-II and p62. Inflammation will be evaluated by measuring the expression of pro-inflammatory cytokines (TNFα, IFNγ, IL-17, and COX2), quantifying mRNA by real-time (RT)- PCR with specific primers. Fibrosis will be evaluated by quantification of mRNA of the related genes Col1a1, α-sma, Snail1, Snail2, TGFβ. Finally, oxydative stress levels will be evaluated by measuring serum markers such as sNOX2-dp, H2O2, and serum hydrogen peroxide (H2O2) breakdown activity (HBA).
- Conditions
- Crohn Disease (CD)
- Being tested
- Clostridum Butyricum Capsule, Trehalose
- Keywords
- Clostridium butyricum, autophagy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clostridum Butyricum CapsuleDietary supplement
Administration of C. butyricum tablets (3 + 3 per day, 27 x 10^5 CFY/day)
TrehaloseDietary supplement
Administration of trehalose at 30 g per day
| Study group | Role | What they receive |
|---|---|---|
| C. butyricum | Experimental | Clostridium butyricum CBM 588 (27 x 10^5 CFU/day) Receives: Dietary Supplement: Clostridum Butyricum Capsule |
| Trehalose | Active comparator | Threhalose (30g/day) Receives: Dietary Supplement: Trehalose |
| C butyricum + trehalose | Experimental | C. butyricum (27 x 10^5 CFU/day) + trehalose (30 g/day) Receives: Dietary Supplement: Clostridum Butyricum Capsule; Dietary Supplement: Trehalose |
| placebo | No intervention | Patients with no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of C. butyricum in stimulating autophagy
We evaluate the stimulation of autophagy measuring the mucosal expression and production of the molecular markers LC3 b II and p62 after treatment with C. butyricum
Measured: 2 months
Safety of administration of C. butyricum
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of C. butyricum in Crohn's disease patients will be evaluated by adverse event monitoring and reporting
Measured: 2 months
Secondary outcomes (2)
Treatment effect comparison
Comparation of the effect on autophagy induction (as mesured by LC3b-II and p62 mucosal production and expression), inflammatory (TNFα, IFNγ, IL-17 and COX2) and fibrosis (Col1a1, α-sma, Snail1, Snail2, TGFβ) markers in C. butyricum, trehalose, and C. butyricum+trehalose group
Measured: 2 months
Oxydative stress measurement and comparation
Measurement and comparation of serum oxydative stress markers (sNOX2-dp, H2O2, and serum hydrogen peroxide [H2O2] breakdown activity - HBA) in the groups
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start8 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Giovanni Addolorata Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza
- Responsible party
- Principal investigator, Cristiano Pagnini, San Giovanni Addolorata Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263880
- Sponsor's protocol ID
- AUTOCD01
- Acronym
- AUTOCD
- Status last verified
- Jul 2026
- First submitted
- 27 Sep 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Therapeutic Application of Clostridium Butyricum in Patiens With Stenosing Crohn's Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT07263880
- Acronym / sponsor ID
- AUTOCD / AUTOCD01
- Conditions
- Crohn Disease (CD)
- Keywords
- Clostridium butyricum, autophagy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- San Giovanni Addolorata HospitalUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza
- Study start
- 8 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 4 Dec 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.
Crohn's disease is a condition of unknown etiology with an immune-mediated pathogenesis. The subgroup of Crohn's disease with a stricturing phenotype represents a particular challenge for clinicians, as currently no effective medical therapies are available for the prevention or treatment of fibrosis. Autophagy is a key mechanism in the regulation of cellular homeostasis, and preliminary reports from our group and others have suggested a potential role in the pathogenesis of fibrostenotic complications in Crohn's disease.
The next-generation probiotic Clostridium butyricum has recently been proposed as a treatment option in several conditions, including inflammatory bowel diseases (IBD). Its beneficial effects are mainly exerted through the production of butyric acid, which in turn plays important roles at the intestinal mucosal level, including the stimulation of autophagy. The possibility of stimulating autophagy in patients with stricturing Crohn's disease may represent a promising therapeutic approach for the prevention and treatment of fibrosis.
This study involves the collection of biopsy and blood samples from 40 patients with stricturing Crohn's disease undergoing colonoscopy. In the two months preceding colonoscopy, patients will be randomized into four groups:
Patients treated with C. butyricum
Patients treated with the autophagy stimulator trehalose
Patients treated with C. butyricum + trehalose
Patients treated with placebo
Laboratory analyses will be performed on biopsy and blood samples to evaluate and quantify molecular mediators involved in inflammation, fibrosis, and autophagy.
Detailed description
Crohn's disease is a chronic, relapsing inflammatory bowel disease with unknown etiology, involving immune dysregulation and microbiota alterations. Stricturing disease (Montreal B2 phenotype) represents a major unmet therapeutic need, as no pharmacological therapies are currently available for intestinal fibrosis, which is often managed surgically.
Autophagy, a key regulator of cellular homeostasis, has been linked to Crohn's disease pathogenesis, with genetic studies identifying polymorphisms in autophagy-related genes. Impaired autophagy may exacerbate inflammation, oxidative stress, and tissue damage. Preliminary data from our group show reduced autophagy in patients with stricturing Crohn's disease compared to those with inflammatory phenotype or healthy controls.
Clostridium butyricum, a next-generation probiotic with strong butyrate-producing activity, exerts anti-inflammatory and mucosal protective effects partly through stimulation of autophagy. Its use may represent a novel therapeutic approach to prevent or mitigate fibrostenotic complications in Crohn's disease.
This is a non-profit, interventional clinical pilot study enrolling 40 patients with stricturing Crohn's disease (B2, Montreal classification; localization L2 or L3). Patients undergoing clinically indicated colonoscopy will be randomized to one of four groups to receive for two months prior to the procedure:
- C. butyricum supplementation
- Trehalose supplementation (a known autophagy inducer)
- Combined C. butyricum + trehalose
- Placebo During colonoscopy, routine biopsies will be obtained, with two additional samples collected for research purposes, along with peripheral blood samples. Laboratory analyses will focus on molecular mediators of inflammation, fibrosis, oxidative stress, and autophagy pathways.
The primary objective is to test the hypothesis that C. butyricum is safe and capable of stimulating local autophagic processes in the intestinal mucosa of patients with stricturing Crohn's disease.
Secondary objectives include evaluating autophagy-related pathways (inflammation, fibrosis, ROS production, NADPH oxidase activity) and comparing outcomes across the four treatment groups. Laboratory procedures will be used to evaluate and quantify, in bioptic and blood samples autophagy, inflammation, fibrosis, and oxidative stress.In particular, autophagy will be evaluated by measurement of the mucosal autophagic markers LC3b-II and p62. Inflammation will be evaluated by measuring the expression of pro-inflammatory cytokines (TNFα, IFNγ, IL-17, and COX2), quantifying mRNA by real-time (RT)- PCR with specific primers. Fibrosis will be evaluated by quantification of mRNA of the related genes Col1a1, α-sma, Snail1, Snail2, TGFβ. Finally, oxydative stress levels will be evaluated by measuring serum markers such as sNOX2-dp, H2O2, and serum hydrogen peroxide (H2O2) breakdown activity (HBA).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| C. butyricum | Experimental | Dietary Supplement: Clostridum Butyricum CapsuleClostridium butyricum CBM 588 (27 x 10^5 CFU/day) |
| Trehalose | Active comparator | Dietary Supplement: TrehaloseThrehalose (30g/day) |
| C butyricum + trehalose | Experimental | Dietary Supplement: Clostridum Butyricum Capsule, Dietary Supplement: TrehaloseC. butyricum (27 x 10^5 CFU/day) + trehalose (30 g/day) |
| placebo | No intervention | –Patients with no treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients with a confirmed diagnosis of Crohn's disease (established according to clinical, endoscopic, histological, and radiological criteria in line with current Italian and European guidelines), with a stricturing phenotype (B2 according to the Montreal classification), determined based on the patient's clinical history and instrumental examinations, with disease localized to the right colon or ileocecal region, followed at the Inflammatory Bowel Disease Outpatient Clinic of the Gastroenterology and Digestive Endoscopy Unit, in whom a colonoscopy with biopsies has been scheduled for clinical indication (disease reassessment, flare-up, or follow-up).
- Patients aged ≥18 and ≤85 years.
- Patients either not receiving any specific immunomodulatory therapy for Crohn's disease or undergoing treatment with mesalazine or sulfasalazine.
- Patients who have been adequately informed about the study protocol and who have understood and voluntarily signed the informed consent form.
Key exclusion criteria (7 listed)
- Other acute or chronic inflammatory bowel diseases (e.g., diverticulitis, infectious colitis, ulcerative colitis).
- Patients receiving treatment for Crohn's disease with immunosuppressive drugs (thiopurines, methotrexate, cyclosporine), biologics (anti-TNFα, vedolizumab, ustekinumab), oral antiJAK or oral/intravenous corticosteroids.
- Immunological or rheumatologic diseases.
- Current or past malignancies.
- Active infections.
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 |
|---|---|---|
| Clostridum Butyricum CapsuleAdministration of C. butyricum tablets (3 + 3 per day, 27 x 10^5 CFY/day) | Dietary supplement | C butyricum + trehalose, C. butyricum |
| TrehaloseAdministration of trehalose at 30 g per day | Dietary supplement | C butyricum + trehalose, Trehalose |
Primary outcome
Efficacy of C. butyricum in stimulating autophagy
Time frame: 2 months
We evaluate the stimulation of autophagy measuring the mucosal expression and production of the molecular markers LC3 b II and p62 after treatment with C. butyricum
Safety of administration of C. butyricum
Time frame: 2 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of C. butyricum in Crohn's disease patients will be evaluated by adverse event monitoring and reporting
2 secondary outcomes
Treatment effect comparison
Time frame: 2 months
Oxydative stress measurement and comparation
Time frame: 2 months
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 4 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Clostridum Butyricum Capsule and Trehalose in people with Crohn Disease (CD), run by San Giovanni Addolorata Hospital 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 4 inclusion and 7 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 4 Sep 2026. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Cristiano Pagnini, MD, PhD (+39 06 7705 1, cpagnini@hsangiovanni.roma.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of C. butyricum in stimulating autophagy (time frame: 2 months). The study lists 2 primary outcomes in all. 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 4 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.