Ulcerative ColitisANEMONENCT07724990
A Specific Probiotic in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis
A study testing For a bipsies and rectal administration in people with Ulcerative Colitis and Crohn Disease, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Probiotics are live microorganisms that provide health benefits when consumed in sufficient amounts. Traditional probiotics, mainly from the Lactobacillus and Bifidobacterium genera, originate from fermented foods or the human gut and are widely used in supplements. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis, Crohn Disease
- What is being tested?
- For a bipsies and rectal administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 14 May 2025to 14 May 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women 18 to 80 years of age at the time of consent
- Previous diagnosis of ulcerative colitis, based on available endoscopic and histopathologic report, at least 3 months before screening
- Mild-to-moderate disease activity based on Modified Mayo Score that should be between 4 and 6 with an endoscopic subscore >1 based on endoscopic evaluation performed during screening phase
- Subjects are permitted to receive a concomitant therapeutic dose of the following IPs: Corticosteroids (≤20 mg/day of prednisone equivalents) at stable dose for at least 2 weeks before screening and mesalazine or other 5-ASA (including salazopyrin) at stable dose for at least 4 weeks before screening
- Ability to provide a written informed consent and to be compliant with the schedule of protocol assessments.
Who cannot join
- concomitant immunosuppressive therapy, including but not limited to thiopurines, methotrexate, anti-TNFalfas, anti-integrins and anti-IL12/23 or JAK inhibitors. Biological therapies should be stopped at least 8 weeks before baseline, except for ustekinumab which should be stopped for at least 12 weeks before baseline, small molecules agent should be discontinued 5 elimination half-lives within baseline. Patients that have been previously treated with ≥ 2 advanced/biological drugs (even if belonging to the same class) will be excluded.
- Intolerance to topical therapy (enemas)
- Allergy to A. muciniphila or any other component of the IP
- Crohn's disease or inflammatory bowel disease unclassified (IBD-U)
- Subject who received IV/intramuscular corticosteroids within 14 days prior to Screening or during the Screening period.
- Subject who received topical therapy (i.e., enema or suppository of aminosalicylates / corticosteroids) within 14 days prior to Screening or during the Screening period.
Show all 13Show fewer
- Subject who received fecal microbial transplantation within 3 months prior to Baseline.
- Subjects with the following chronic or active infections:
- Active, chronic, or recurrent infection that based on the Investigator's clinical assessment makes the subject unsuitable candidate for the study
- Infection with C. difficile, intestinal pathogen bacteria, intestinal parasites as identified during Screening as per clinical practice,
- Are infected with human immunodeficiency virus (HIV),
- Subject who has any condition including any physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study.
- Pregnancy and breastfeeding
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
Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
Roma, RM, 00146
Antonio Gasbarrini, 0630157104, antonio.gasbarrini@unicatt.it
About this study
Official title: A. M in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis: a Pilot,Phase 2A, Single-arm, Interventional Study
Probiotics are live microorganisms that provide health benefits when consumed in sufficient amounts. Traditional probiotics, mainly from the Lactobacillus and Bifidobacterium genera, originate from fermented foods or the human gut and are widely used in supplements. Although considered safe and easy to produce, they are not specifically designed to treat diseases, and no official health claims have been approved by EFSA. Advances in microbiome research have led to the discovery of Next-Generation Probiotics (NGPs), which are newly identified gut microbes associated with health and offer promising therapeutic potential despite lacking a long history of safe use.
Read the detailed description
The concept of probiotics dates back to 1907, when Elie Metchnikoff observed that elderly Bulgarian populations consuming fermented dairy products, such as yogurt rich in lactic acid bacteria (LAB), appeared to have increased longevity. This observation formed the basis for the development of traditional probiotics.
Traditional probiotics are defined as live microorganisms that confer a health benefit when administered in adequate amounts. These microbes are typically derived from fermented foods or the human gastrointestinal tract. Most belong to a limited number of well-characterized genera, particularly Lactobacillus and Bifidobacterium. Certain strains of these bacteria are recognized as safe and have been granted Qualified Presumption of Safety (QPS) status by the European Food Safety Authority (EFSA). In addition, they are technologically robust, meaning they can be easily cultivated and mass-produced for industrial applications.
Despite their popularity and widespread use in dietary supplements and functional foods, traditional probiotics are not specifically developed as treatments for diseases. Their mechanisms of action include modulation of gut microbiota, enhancement of the gut barrier, and interaction with the immune system. However, most supporting evidence comes from laboratory (in vitro), animal, or ex vivo studies rather than strong clinical trials. As a result, EFSA has evaluated more than 400 probiotic-related claims but has not approved any specific health claims due to insufficient conclusive evidence.
In recent years, advances in microbiota and microbiome research-particularly through metagenomics and microbial profiling-have significantly expanded our understanding of the gut ecosystem. It is now well established that dysbiosis, or imbalance in gut microbiota composition, is associated with a wide range of diseases, including metabolic, immune, and inflammatory disorders.
These scientific developments have led to the identification of new microorganisms that are associated with healthy individuals rather than traditional dietary sources. These microbes are classified as Next-Generation Probiotics (NGPs) or Live Biotherapeutic Products (LBPs). Unlike traditional probiotics, NGPs are not restricted to classical genera and do not have a long history of safe human use. Instead, they are often identified through comparative studies analyzing differences between healthy and diseased microbiomes.
NGPs represent a promising new frontier in microbiota-based therapies, as they may be specifically selected or engineered to target particular diseases or health conditions. A growing number of potentially beneficial species have been identified, opening new opportunities for precision medicine and personalized interventions based on gut microbiota composition.
- Conditions
- Ulcerative Colitis, Crohn Disease
- Being tested
- For a bipsies, rectal administration
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
For a bipsiesDiagnostic test
For the collection of a few additional biopsies
rectal administrationDietary supplement
rectal administration of a specific probiotic
| Study group | Role | What they receive |
|---|---|---|
| Type of patients | Experimental | patients with UC and CD Receives: Diagnostic Test: For a bipsies; Dietary Supplement: rectal administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of rectal administered a specific probiotic in Rectal mucosal healing
The primary aim of this study is to evaluate the effect of rectal administered a specific probiotic on gut microbiota in patients with UC and CD for Rectal Mucosal Healing with mayo score. Rectal mucosal healing assessed by Mayo Endoscopic Subscore (MES) (range 0-3; lower scores indicate better mucosal healing and lower disease activity).
Measured: 1 year
Secondary outcomes (3)
Evaluate the tolerability of rectal a specific probiotic in Rectal Mucosal healing
Tolerability of rectally administered probiotic assessed by the incidence of adverse events and treatment discontinuations.
Measured: 1 year
Evaluate the quality of life
Quality of life assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ) (range 32-224; higher scores indicate better quality of life).
Measured: 1 year
evaluate the feasibility of a specific probiotic
To evaluate the feasibility of a specific probiotic rectal administration in a cohort of patients with mild-to-moderate ulcerative colitis by nursing notes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start14 May 2025
- Primary completion14 Sep 2026 (estimated)
- Study completion14 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Gasbarrini, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724990
- Sponsor's protocol ID
- 6991
- Acronym
- ANEMONE
- Status last verified
- Jul 2026
- First submitted
- 22 Apr 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A. M in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis: a Pilot,Phase 2A, Single-arm, Interventional Study
- ClinicalTrials.gov ID
- NCT07724990
- Acronym / sponsor ID
- ANEMONE / 6991
- Conditions
- Ulcerative Colitis, Crohn Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- 14 Sep 2026 (estimated)
- Study completion
- 14 May 2027 (estimated)
- First posted
- 24 Jul 2026 (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.
Probiotics are live microorganisms that provide health benefits when consumed in sufficient amounts. Traditional probiotics, mainly from the Lactobacillus and Bifidobacterium genera, originate from fermented foods or the human gut and are widely used in supplements. Although considered safe and easy to produce, they are not specifically designed to treat diseases, and no official health claims have been approved by EFSA. Advances in microbiome research have led to the discovery of Next-Generation Probiotics (NGPs), which are newly identified gut microbes associated with health and offer promising therapeutic potential despite lacking a long history of safe use.
Detailed description
The concept of probiotics dates back to 1907, when Elie Metchnikoff observed that elderly Bulgarian populations consuming fermented dairy products, such as yogurt rich in lactic acid bacteria (LAB), appeared to have increased longevity. This observation formed the basis for the development of traditional probiotics.
Traditional probiotics are defined as live microorganisms that confer a health benefit when administered in adequate amounts. These microbes are typically derived from fermented foods or the human gastrointestinal tract. Most belong to a limited number of well-characterized genera, particularly Lactobacillus and Bifidobacterium. Certain strains of these bacteria are recognized as safe and have been granted Qualified Presumption of Safety (QPS) status by the European Food Safety Authority (EFSA). In addition, they are technologically robust, meaning they can be easily cultivated and mass-produced for industrial applications.
Despite their popularity and widespread use in dietary supplements and functional foods, traditional probiotics are not specifically developed as treatments for diseases. Their mechanisms of action include modulation of gut microbiota, enhancement of the gut barrier, and interaction with the immune system. However, most supporting evidence comes from laboratory (in vitro), animal, or ex vivo studies rather than strong clinical trials. As a result, EFSA has evaluated more than 400 probiotic-related claims but has not approved any specific health claims due to insufficient conclusive evidence.
In recent years, advances in microbiota and microbiome research-particularly through metagenomics and microbial profiling-have significantly expanded our understanding of the gut ecosystem. It is now well established that dysbiosis, or imbalance in gut microbiota composition, is associated with a wide range of diseases, including metabolic, immune, and inflammatory disorders.
These scientific developments have led to the identification of new microorganisms that are associated with healthy individuals rather than traditional dietary sources. These microbes are classified as Next-Generation Probiotics (NGPs) or Live Biotherapeutic Products (LBPs). Unlike traditional probiotics, NGPs are not restricted to classical genera and do not have a long history of safe human use. Instead, they are often identified through comparative studies analyzing differences between healthy and diseased microbiomes.
NGPs represent a promising new frontier in microbiota-based therapies, as they may be specifically selected or engineered to target particular diseases or health conditions. A growing number of potentially beneficial species have been identified, opening new opportunities for precision medicine and personalized interventions based on gut microbiota composition.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type of patients | Experimental | Diagnostic Test: For a bipsies, Dietary Supplement: rectal administrationpatients with UC and CD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women 18 to 80 years of age at the time of consent
- Previous diagnosis of ulcerative colitis, based on available endoscopic and histopathologic report, at least 3 months before screening
- Mild-to-moderate disease activity based on Modified Mayo Score that should be between 4 and 6 with an endoscopic subscore >1 based on endoscopic evaluation performed during screening phase
- Subjects are permitted to receive a concomitant therapeutic dose of the following IPs: Corticosteroids (≤20 mg/day of prednisone equivalents) at stable dose for at least 2 weeks before screening and mesalazine or other 5-ASA (including salazopyrin) at stable dose for at least 4 weeks before screening
- Ability to provide a written informed consent and to be compliant with the schedule of protocol assessments.
Key exclusion criteria (13 listed)
- concomitant immunosuppressive therapy, including but not limited to thiopurines, methotrexate, anti-TNFalfas, anti-integrins and anti-IL12/23 or JAK inhibitors. Biological therapies should be stopped at least 8 weeks before baseline, except for ustekinumab which should be stopped for at least 12 weeks before baseline, small molecules agent should be discontinued 5 elimination half-lives within baseline. Patients that have been previously treated with ≥ 2 advanced/biological drugs (even if belonging to the same class) will be excluded.
- Intolerance to topical therapy (enemas)
- Allergy to A. muciniphila or any other component of the IP
- Crohn's disease or inflammatory bowel disease unclassified (IBD-U)
- Subject who received IV/intramuscular corticosteroids within 14 days prior to Screening or during the Screening period.
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 |
|---|---|---|
| For a bipsiesFor the collection of a few additional biopsies | Diagnostic test | Type of patients |
| rectal administrationrectal administration of a specific probiotic | Dietary supplement | Type of patients |
Primary outcome
Evaluate the effect of rectal administered a specific probiotic in Rectal mucosal healing
Time frame: 1 year
The primary aim of this study is to evaluate the effect of rectal administered a specific probiotic on gut microbiota in patients with UC and CD for Rectal Mucosal Healing with mayo score. Rectal mucosal healing assessed by Mayo Endoscopic Subscore (MES) (range 0-3; lower scores indicate better mucosal healing and lower disease activity).
3 secondary outcomes
Evaluate the tolerability of rectal a specific probiotic in Rectal Mucosal healing
Time frame: 1 year
Evaluate the quality of life
Time frame: 1 year
evaluate the feasibility of a specific probiotic
Time frame: 1 year
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 27 Jul 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 study testing For a bipsies and rectal administration in people with Ulcerative Colitis and Crohn Disease, run by Catholic University of the Sacred Heart 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 13 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 27 Jul 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.
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 Antonio Gasbarrini (0630157104, antonio.gasbarrini@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of rectal administered a specific probiotic in Rectal mucosal healing (time frame: 1 year). 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 27 Jul 2026.