TrIuMPH: Treating IBS with an Intestinal Microbiota Product for Health
Research type
Research Study
Full title
A randomised, double blind, placebo controlled, phase II trial assessing the effect of EBX-102-02 in patients with IBS-C
IRAS ID
1009182
Contact name
Julie Bakobaki
Contact email
Sponsor organisation
EnteroBiotix Limited
Research summary
The aim of the study is to assess the safety and efficacy of EBX-102-02 in patients with constipation
predominant Irritable Bowel Syndrome (IBS-C). Irritable bowel syndrome (IBS) is a common
condition that affects the digestive system. It causes symptoms including abdominal pain, bloating,
and constipation that can come and go over time. It can be very frustrating to live with and can have
a big impact on everyday life. The exact cause is unknown. In the study we will be looking at the
impact of EBX-102-02 on IBS-C symptoms such as pain, bloating, stool consistency and frequency.
We will also be looking at quality of life, anxiety and depression, and will take samples from
participants to look at changes in methane in the breath and the types and amount of different
microbes in the intestine.
Current treatments can relieve the symptoms but there is currently no cure. There is increased
interest in the role of the gut microbiome in IBS. The intestinal microbiome is a term for the many
bacteria and other microbes that usually live in your gut. The gut microbiome plays an important
role in health and normally there is a lot of variety, also called diversity, in the type of microbes.
People with a lower diversity are at higher risk of a number of diseases including IBS. EBX-102-02
capsules contain dried, intestinal microorganisms taken from carefully screened pooled human stool
samples from healthy donors and has the potential to improve diversity. The study will be conducted
in 2 centres - The Functional Gut Clinics, based in Manchester & London. 60 participants will be
randomised in a 2:1 ratio, with approx. 40 given EBX-102-02 and 20 a matching placebo. The total
period on study for an individual participant will be approximately 9 weeks.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
23/WM/0274
Date of REC Opinion
23 Jan 2024
REC opinion
Further Information Favourable Opinion