Clinical trial for Ulcerative Colitis
Official title A Specific Probiotic in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis
ClinicalTrials.gov ID: NCT07724990
What this study is testing
- What it's testing
- The study wants to find out whether this next‑generation probiotic can alter the gut microbiome of patients with ulcerative colitis.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
- people are permitted to receive a concomitant therapeutic dose of the following IPs: Corticosteroids (≤20 mg/day of prednisone equivalents) at stable...
- Ability to provide a written informed consent and to be compliant with the schedule of protocol assessments.
You likely can't join if
- concomitant immunosuppressive therapy, including but not limited to thiopurines, methotrexate, anti-TNFalfas, anti-integrins and anti-IL12/23 or JAK...
- 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...
See the full eligibility criteria
- 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
- people 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...
- Ability to provide a written informed consent and to be compliant with the schedule of protocol assessments.
- concomitant immunosuppressive therapy, including but not limited to thiopurines, methotrexate, anti-TNFalfas, anti-integrins and anti-IL12/23 or JAK inhibitors.
- 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.
- 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...
- Pregnancy and breastfeeding
The study team makes the final eligibility decision.
Where it is enrolling
- Roma, RM, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Roma, RM, Italy. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.