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New treatment option for Ulcerative Colitis (UC)
Official title AIM-IBD: A Microbiome-Targeted Supplement in Mild-to-Moderate Ulcerative Colitis
ClinicalTrials.gov ID: NCT07619638
What this study is testing
- What it's testing
- This Phase 2b randomized, double-blind, placebo-controlled, multicenter trial will evaluate the efficacy and safety of a once-daily oral microbiome-targeted food supplement compared with matching placebo in adults with mild-to-moderate, objectively active ulcerative colitis. The supplement is food-grade and is intended for use either alongside stable standard ulcerative colitis therapy (5-aminosalicylic acid/mesalamine) or in participants not currently on any inflammatory bowel disease therapy.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 75
You may be able to join if
- Adults aged 18 to 75 years inclusive at screening.
- Documented diagnosis of ulcerative colitis established at least 3 months before screening, based on standard clinical, endoscopic, and histologic...
- Mild-to-moderate active ulcerative colitis defined by a partial Mayo score of 4 to 8 at screening.
- Rectal bleeding subscore of at least 1 at screening.
- Objective intestinal inflammation defined by fecal calprotectin of at least 250 micrograms per gram at screening, measured by the central laboratory...
You likely can't join if
- Crohn disease, inflammatory bowel disease-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or any other...
- Severe ulcerative colitis, acute severe ulcerative colitis, fulminant colitis, toxic megacolon, or any disease severity requiring immediate...
- Isolated ulcerative proctitis (E1 only) outside the prespecified 10 percent enrollment cap.
- Use of biologics, Janus kinase (JAK) inhibitors, sphingosine-1-phosphate (S1P) receptor modulators, or systemic immunosuppressants within 8 weeks...
- Systemic corticosteroids within 4 weeks before randomization.
- Current budesonide-class therapy at baseline.
See the full eligibility criteria
Who can join
- Adults aged 18 to 75 years inclusive at screening.
- Documented diagnosis of ulcerative colitis established at least 3 months before screening, based on standard clinical, endoscopic, and histologic criteria.
- Mild-to-moderate active ulcerative colitis defined by a partial Mayo score of 4 to 8 at screening.
- Rectal bleeding subscore of at least 1 at screening.
- Objective intestinal inflammation defined by fecal calprotectin of at least 250 micrograms per gram at screening, measured by the central laboratory or by a validated harmonized assay.
- Eligible disease extent: left-sided colitis or extensive/pancolitis. Proctosigmoiditis is eligible if inflammation extends beyond isolated proctitis and is measurable by study endoscopy. Isolated ulcerative proctitis...
- Either no current ulcerative colitis-directed therapy, or stable oral and/or rectal 5-aminosalicylate (5-ASA, mesalamine) therapy at unchanged dose for at least 8 weeks before randomization, with intent to continue at...
- Able and willing to provide written informed consent.
- Able and willing to comply with study visits, stool sampling, endoscopy, medication restrictions, and diary/patient-reported outcome completion.
- Participants of childbearing potential must agree to use a highly effective method of contraception during dosing and for at least 4 weeks after the last dose, in accordance with EMA/CTFG guidance and local ethics...
What rules you out
- Crohn disease, inflammatory bowel disease-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or any other non-ulcerative-colitis form of colitis.
- Severe ulcerative colitis, acute severe ulcerative colitis, fulminant colitis, toxic megacolon, or any disease severity requiring immediate hospitalization or treatment escalation in the investigator's judgment.
- Isolated ulcerative proctitis (E1 only) outside the prespecified 10 percent enrollment cap.
- Use of biologics, Janus kinase (JAK) inhibitors, sphingosine-1-phosphate (S1P) receptor modulators, or systemic immunosuppressants within 8 weeks before randomization, or planned use of any of these during the trial.
- Systemic corticosteroids within 4 weeks before randomization.
- Current budesonide-class therapy at baseline.
- Rectal or topical corticosteroids unless discontinued at least 2 weeks before randomization.
- Antibiotic use within 4 weeks before randomization, except topical antibiotics not expected to affect the gut microbiota.
- Probiotic, prebiotic, synbiotic, postbiotic, fermented microbiome-directed supplement, or other non-study microbiome-directed product within 4 weeks before randomization, or planned use during the trial.
- Active or recent Clostridioides difficile infection within 12 weeks before screening (screening uses a two-step algorithm: glutamate dehydrogenase plus toxin A/B enzyme immunoassay, with reflex nucleic acid...
- Positive stool test for any clinically relevant enteric infection at screening, per local diagnostic standard operating procedures.
- Prior colectomy, planned colectomy, known dysplasia requiring intervention, or colorectal cancer.
- Pregnancy, breastfeeding, or planned pregnancy during the trial.
- Uncontrolled clinically significant comorbidity, including but not limited to uncontrolled diabetes, advanced liver or renal disease, unstable cardiovascular disease, immunodeficiency, active malignancy other than...
- Known allergy, intolerance, or contraindication to any component of the investigational product or matching placebo.
- Participation in another treatment clinical trial within 30 days before screening.
- Any other condition that, in the investigator's judgment, would make participation unsafe or compromise protocol adherence.
The study team makes the final eligibility decision.
Where it's taking place
- Izmir, Turkey (Türkiye)
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 - 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Izmir, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.