A Specific Probiotic in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis

NCT07724990 | Recruiting

• 1 other identifier: 6991
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ulcerative Colitis; Crohn Disease

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year

Secondary Outcomes (3)

• Evaluate the tolerability of rectal a specific probiotic in Rectal Mucosal healing

  1 year

• Evaluate the quality of life

  1 year

• evaluate the feasibility of a specific probiotic

  1 year

Study Arms (1)

Type of patients

EXPERIMENTAL

patients with UC and CD

Diagnostic Test: For a bipsies; Dietary Supplement: rectal administration

Interventions

For a bipsies DIAGNOSTIC_TEST

For the collection of a few additional biopsies

Type of patients

rectal administration DIETARY_SUPPLEMENT

rectal administration of a specific probiotic

Type of patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Roma, RM, 00146, Italy

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Interventions

Administration, Rectal

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Administration, Mucosal; Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Antonio Gasbarrini

CONTACT

0630157104; antonio.gasbarrini@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical director

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: July 24, 2026
• Study Start: May 14, 2025
• Primary Completion (Estimated): September 14, 2026
• Study Completion (Estimated): May 14, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

IT (1)