**EnteroBiotix, Ltd.**, a biotechnology firm at the clinical stage, specializing in advanced microbiome therapeutics, has announced the fulfillment of participant recruitment for their phase 2 TrIuMPH clinical trial. This study is evaluating the safety, tolerability, and effectiveness of EBX-102-02, their pioneering treatment for irritable bowel syndrome (IBS).
The TrIuMPH trial, which is randomized, double-blind, and placebo-controlled, involved 122 IBS sufferers across two UK locations. Participants, classified as having severe IBS-C or IBS-D based on Rome IV criteria, were divided into groups to receive EBX-102-02 or a placebo, administered at two separate intervals over one week, with follow-ups extending over six weeks.
The trial’s main aim is to assess the safety and tolerability of EBX-102-02 in those with severe IBS. Additional aims include measuring effectiveness, gut microbiome changes, and relevant biomarkers.
**Dr. James McIlroy MBChB, CEO of EnteroBiotix**, expressed gratitude to participants and researchers for their role in the swift progress of EBX-102-02. Achieving this benchmark ahead of plans showcases the commitment of their clinical team and cooperation with the Functional Gut Clinic. The swift recruitment highlights a significant demand for innovative IBS solutions targeting microbiome disruptions, with high hopes for preliminary results expected early next year.
EBX-102-02 represents an advanced, comprehensive drug candidate featuring a richly varied microbial community and key functional elements to rejuvenate and bolster the microbiome. This treatment is available as an easy-to-ingest capsule, designed for stability at room temperature.
The TrIuMPH trial, focused on IBS, is structured to evaluate EBX-102-02’s safety and tolerability in IBS patients, exploring this next-gen microbiome therapeutic.
Across TrIuMPH, 122 IBS patients were recruited at two facilities. This includes 62 with IBS-C and 60 with IBS-D, who were administered EBX-102-02 or a placebo, with a follow-up duration of six weeks.
IBS presents as a chronic, recurring GI disorder, causing symptoms such as sustained abdominal pain, cramping, bloating, and altered bowel movements, ranging between constipation, diarrhea, or both. It’s estimated that IBS symptoms affect up to 1 in 8 individuals, equally divided between constipation (IBS-C) and diarrhea (IBS-D) sufferers. In America alone, IBS leads to direct healthcare costs estimated at $10 billion annually, while indirect costs reach $20 billion (Nellesen et al., 2013).
**EnteroBiotix** is a clinical-stage biotech firm crafting treatments for gastrointestinal and liver ailments. Their solutions incorporate rich microbial ecosystems stabilized through proprietary technology, promoting gut health by enhancing the gut microbiome.
The **Functional Gut Clinic (FGC)** is the premier independent provider of gastrointestinal physiological testing and diagnostics in the UK. It renders services both privately and through the NHS across the nation and is the only independent GI physiology clinic boasting certifications from IQIPS, UKAS, and the CQC.