AIM-IBD: A Microbiome-Targeted Supplement in Mild-to-Moderate Ulcerative Colitis

NCT07619638 | Recruiting DMC

• 1 other identifier: Enbiosis_AIM-IBD
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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. Approximately 162 participants will be enrolled at university hospital centers in Turkey and randomized in a 1:1 ratio to receive either the food supplement or matching placebo for 24 weeks, in addition to their existing background therapy as defined by eligibility. The primary objective is to determine whether the supplement increases the proportion of participants achieving composite clinical-plus-biochemical remission at Week 24. This composite endpoint requires absence of rectal bleeding, improvement in stool frequency, fecal calprotectin ≤250 micrograms/g, and no rescue therapy, prohibited treatment escalation, ulcerative colitis-related hospitalization, colectomy, or discontinuation for lack of efficacy before Week 24. Key secondary endpoints include endoscopic improvement, deep biochemical remission, change in fecal calprotectin, change in partial Mayo score, corticosteroid-free composite remission, change in quality of life, change in C-reactive protein, time to treatment failure, and safety. Exploratory analyses will assess stool microbiome composition, eukaryotic carriage including Blastocystis, and associations between baseline microbiome features and treatment response.

Conditions

Ulcerative Colitis (UC); Inflammatory Bowel Disease (IBD); Colitis

Keywords

Ulcerative colitis; Inflammatory bowel disease; Microbiome; Gut microbiota; Fecal calprotectin; Artificial intelligence; Partial Mayo score; 5-ASA; Mesalamine; Nutraceutical; Placebo-controlled trial; Blastocystis; Microbiome-targeting nutraceutical

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Achieving Composite Clinical-Plus-Biochemical Remission at Week 24

  Responder defined by all four criteria at Week 24: (1) rectal bleeding subscore = 0 on the Mayo 0-3 scale (lower = less bleeding; 0 = no blood seen); (2) stool frequency subscore ≤1 on the Mayo 0-3 scale (lower = fewer stools above the participant's normal) with at least a 1-point decrease from baseline; (3) fecal calprotectin ≤250 µg/g (lower = less mucosal inflammation), measured centrally; (4) no rescue therapy, prohibited escalation, UC-related hospitalization, colectomy, or discontinuation for lack of efficacy through Week 24. Participants not meeting any criterion, or with missing Week 24 data, are counted as non-responders (non-responder imputation). Higher proportion = greater treatment benefit. Analyzed in the intention-to-treat population using stratified Cochran-Mantel-Haenszel adjusted for randomization stratification factors, reporting absolute risk difference with Newcombe 95% CI.

  Baseline to Week 24

Secondary Outcomes (10)

• Proportion of Participants With Endoscopic Improvement at Week 24

  Baseline to Week 24

• Proportion of Participants With Deep Biochemical Remission at Week 24

  Baseline to Week 24

• Change in Fecal Calprotectin From Baseline to Week 24

  Baseline to Week 24

• Change in Fecal Calprotectin From Baseline to Week 12

  Baseline to Week 12

• Proportion of Participants With Corticosteroid-Free Composite Remission at Week 24

  Baseline to Week 24

Study Arms (2)

Microbiome-Targeting Investigational Product

EXPERIMENTAL

Participants assigned to this arm will receive the microbiome-targeting investigational product orally once daily for 24 weeks, in addition to either no background ulcerative colitis therapy or stable 5-aminosalicylic acid/mesalamine therapy at an unchanged dose, according to eligibility criteria. Rescue therapy or treatment escalation is permitted at any time if clinically needed.

Dietary Supplement: Microbiome-Targeting Nutraceutical

Placebo

PLACEBO COMPARATOR

Participants assigned to this arm will receive matching placebo orally once daily for 24 weeks, in addition to either no background ulcerative colitis therapy or stable 5-aminosalicylic acid/mesalamine therapy at an unchanged dose, according to eligibility criteria. Rescue therapy or treatment escalation is permitted at any time if clinically needed.

Dietary Supplement: Placebo

Interventions

Microbiome-Targeting Nutraceutical DIETARY_SUPPLEMENT

The investigational product is an oral microbiome-targeting preparation administered once daily for 24 weeks. It is intended to modulate gut microbial ecology and/or microbial metabolite production in adults with mild-to-moderate ulcerative colitis. The dosage form, dose, composition class, storage conditions, and batch-release specifications are documented in the study protocol and investigational product dossier reviewed by the ethics committee and relevant regulatory authority.

Microbiome-Targeting Investigational Product

Placebo DIETARY_SUPPLEMENT

The placebo is an oral matching preparation administered once daily for 24 weeks. It contains inactive excipients only and is matched to the investigational product in appearance, packaging, administration schedule, and organoleptic characteristics, including color, taste, smell, and mouthfeel, as closely as technically feasible.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 (E1 only) is eligible only within a prespecified cap not exceeding 10 percent of total enrollment.
• 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 the same unchanged dose through Week 24 unless rescue therapy is clinically required.
• 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 requirements.

You may not qualify if:

• 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 amplification testing for discordant results).
• 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 adequately treated non-melanoma skin cancer, or any other condition compromising participant safety or interpretation of study results.
• Known allergy, intolerance, or contraindication to any component of the investigational product or matching placebo.

Sponsors & Collaborators

• ENBIOSIS BIOTECHNOLOGIES: lead
• Aydin Adnan Menderes University: collaborator
• Dokuz Eylul University: collaborator
• Tepecik Training and Research Hospital: collaborator
• Ege University Medical School: collaborator

Study Sites (1)

Ege University

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases; Colitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Varol TUNALI

  Enbiosis Biotechnology Limited

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Varol TUNALI, Dr.

CONTACT

+905556303231; vtunali@enbiosis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, site study staff, outcome assessors, endoscopy readers, central laboratory personnel, microbiome and metabolomics analysts, and the primary trial statistician will remain blinded to treatment allocation until database lock. The investigational product and placebo will be matched in appearance, packaging, administration schedule, and organoleptic characteristics as closely as technically feasible. The randomization schedule will be generated and held by an independent statistician or designated unblinded party who is not involved in participant recruitment, clinical care, outcome assessment, or primary analysis. Emergency unblinding will be permitted only when knowledge of treatment allocation is essential for immediate clinical management and will be documented according to the study's standard operating procedure. Blinding integrity will be assessed at Weeks 12 and 24 using participant and investigator treatment-guess questionnaires.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer (CMO)

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning 9 months and ending 36 months following publication of the primary results.
• Access Criteria: Requests will be reviewed by the sponsor's independent data-access committee. Data will be shared under a signed data-access agreement. Proposed analyses must be consistent with the scope of the original participant consent and applicable Turkish (KVKK) and EU (GDPR) data-protection regulations. Priority will be given to requests for scientific replication, secondary analyses, and individual participant data meta-analyses.

Locations

TU (1)