CompletedPhase IIInterventional

Treating IBS with an Intestinal Microbiota Product for Health - TrIuMPH

The TrIuMPH study is looking for volunteers with Irritable Bowel Syndrome (IBS), specifically those who experience constipation (IBS-C) or diarrhoea (IBS-D). Researchers want to see if a new capsule treatment called EBX-102 is safe and effective in improving IBS symptoms. IBS is a common condition causing ongoing digestive problems like cramps, bloating, diarrhoea, and constipation. This new treatment contains beneficial gut bacteria and aims to improve the balance of microbes in your gut. If you are aged 18 to 70 and have IBS-C, you might be able to take part. The study involves taking capsules and having assessments over about 9 weeks. It’s being run in Manchester and London.

At a glance

Status

Completed

Phase

Phase II

Sponsor

EnteroBiotix Limited

Enrolment target

120

Start

11 Mar 2024

Estimated completion

11 Nov 2024

Irritable bowel syndrome (IBS)

What is this study about?

Irritable Bowel Syndrome (IBS) is a common and often frustrating condition that affects the digestive system. Many people with IBS experience symptoms like stomach cramps, bloating, and changes in their bowel habits – either constipation, diarrhoea, or sometimes both. These symptoms can come and go, lasting for days or even months, and can really impact daily life. While we don't know the exact cause of IBS, current treatments usually focus on helping to ease these symptoms.

There's a lot of interest in how the tiny living organisms in our gut, called the gut microbiota, might play a role in IBS. This study, called TrIuMPH, is testing a new treatment called EBX-102. These capsules contain a mix of dried, good bacteria and other tiny organisms. They come from carefully checked human stool (poo) samples. The idea is that these capsules could help to improve the balance of healthy microbes in your gut, which might in turn help your IBS symptoms.

This is a 'Phase II' study, which means it's one of the earlier steps in testing a new treatment. The main goals are to check if EBX-102 is safe for people with IBS and if it helps to reduce their symptoms. The study is specifically looking at people who experience constipation-predominant IBS (IBS-C) and diarrhoea-predominant IBS (IBS-D).

Key takeaways

The study is testing a new capsule treatment (EBX-102) for IBS.
It aims to check safety and how well it improves IBS symptoms, particularly constipation or diarrhoea.
The treatment contains beneficial gut microbes from human stool samples.
Participation involves taking capsules and various health checks over about 9 weeks.
The study is running in Manchester and London.
There are potential risks like temporary stomach upset or discomfort from tests, but measures are in place to ensure safety.

Who may be eligible?

To join this study, you need to be an adult between 18 and 70 years old. You must have been diagnosed with Irritable Bowel Syndrome (IBS-C) where constipation is the main issue. You also need to be willing to stop taking any other medications for your bowel habits, and avoid over-the-counter probiotics or prebiotics, throughout the study.

If you are a woman who could get pregnant, you’ll need to have a negative pregnancy test and agree to use effective birth control methods during the study. Similarly, men will need to use reliable contraception. This is to ensure the safety of any potential unborn child, as the effects of the study drug on pregnancy are not fully known.

You cannot join if you are pregnant or breastfeeding, or if you have upcoming surgery requiring a general anaesthetic. You also can’t take part if you plan to make big changes to your diet, unless you're already on a special diet like a low FODMAP diet and plan to stick with it.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Do you have a diagnosis of Irritable Bowel Syndrome with constipation (IBS-C)?
Are you willing to stop other bowel-related medications and over-the-counter probiotics during the study?
If you are a woman who could get pregnant, are you willing to use effective birth control?

Answer every question to see your result.

What does participation involve?

If you decide to take part and meet the study requirements, your journey will last about 9 weeks in total. First, there's a screening period of at least two weeks to confirm your IBS diagnosis. Once approved, you'll be randomly assigned to either receive the active treatment (EBX-102 capsules) or a placebo (a dummy capsule with no medicine in it). You won't know which one you're getting, and neither will your study doctor.

Over two days, one week apart, you'll take 8 capsules. After the last dose, there will be a 6-week follow-up period. Throughout this time, you'll have various assessments. This includes providing your medical history, having a physical check-up, vital signs taken (like blood pressure), an ECG (heart trace), blood tests, and stool (poo) samples. You'll also fill out questionnaires, keep a daily diary, and might have breath tests. All these steps help the researchers understand how the treatment is working and make sure you're safe.

Potential risks and benefits

Like all research studies, there are some potential risks and inconveniences. You might need procedures more often than usual, such as blood tests which could cause bruising, discomfort, or a small risk of infection. The study treatment itself will be given in a clinic with trained staff and emergency equipment ready, just in case. The EBX-102 capsules might cause temporary side effects like stomach pain, bloating, or diarrhoea, but these often resolve within a few days. There's also a very small theoretical risk of being exposed to unwanted germs from the product, but the company takes strong steps to carefully screen and ensure the safety of the starting materials. It's important to know that there could be unknown side effects, and if any new safety information comes up, you'll be informed immediately. You are free to withdraw from the study at any time and for any reason, without it affecting your medical care.

Locations (2)

The Functional Gut Clinic (Manchester)
City only
Manchester, England
The Functional Gut Clinic
Approximate
London, England

Common questions

What is IBS?

IBS stands for Irritable Bowel Syndrome, a common gut condition causing symptoms like stomach cramps, bloating, diarrhoea, and constipation.

What is EBX-102?

EBX-102 is a new capsule treatment made from dried gut bacteria and other microbes from carefully screened human stool samples, aiming to improve gut health.

Where is the study happening?

The study is taking place in two locations: The Functional Gut Clinics in Manchester and London.

How long will I be in the study?

The total time for an individual taking part is about 9 weeks, including screening, treatment, and follow-up.

Who is paying for this study?

The study is funded by EnteroBiotix Ltd, the company developing the treatment.

How to find out more

Shinofa Rizan

clinops@enterobiotix.com - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.