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

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

Interventions

DIETARY_SUPPLEMENT

Microbiome-Targeting Nutraceutical

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.

DIETARY_SUPPLEMENT

Placebo

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.

Sponsors & Collaborators

• Aydin Adnan Menderes University

  collaborator OTHER

• Ege University Medical School

  collaborator OTHER

• Dokuz Eylul University

  collaborator OTHER

• Tepecik Training and Research Hospital

  collaborator OTHER

• ENBIOSIS BIOTECHNOLOGIES

  lead INDUSTRY

Principal Investigators

• Varol TUNALI · Enbiosis Biotechnology Limited

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-10

Primary Completion

2027-05-30

Completion

2027-11-30

Countries

• Turkey (Türkiye)

Study Locations