RecruitingPhase IIInterventional

Restoring intestinal symbiosis for efficacy in IBS

This research is investigating a new oral capsule treatment, EBX-102, for Irritable Bowel Syndrome with Constipation (IBS-C). IBS-C can significantly affect daily life, and this study believes that problems with gut bacteria might be a cause. The EBX-102 capsules contain dried healthy gut bacteria and are designed to help restore balance in the gut. The study will test two versions of EBX-102, comparing them to a dummy pill (placebo). Around 300 adults with IBS-C, aged 18 to 70, will take part for up to 18 weeks. The aim is to see if this treatment can improve IBS symptoms and overall quality of life.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

EnteroBiotix Limited

Enrolment target

300

Start

08 May 2026

Estimated completion

31 Dec 2026

Irritable Bowel Syndrome - constipation predominant (IBS-C)

What is this study about?

Irritable Bowel Syndrome with Constipation (IBS-C) is a common condition that can cause tummy pain, bloating, and difficulty going to the toilet. It can really impact your daily life. Scientists don't fully understand why IBS-C happens, but they think that an imbalance of bacteria in your gut (your 'gut microbiome') might play a big part. This study is exploring a new way to help by trying to restore this balance.

The study treatment is called EBX-102, and it comes in a capsule form that you swallow. These capsules contain healthy, dried gut bacteria taken from thoroughly checked stool samples of healthy donors. There are two slightly different versions of EBX-102 being tested. The idea is that by introducing these helpful bacteria, it could improve your IBS-C symptoms, such as how often you go to the toilet and how severe your tummy pain is. Previous early research with one version of EBX-102 showed promising results in improving people's symptoms.

This is a 'Phase II' study, which means it's one of the earlier steps in testing a new medicine. It aims to find out if the treatment is safe and if it works for people with IBS-C. A total of about 300 adults in the UK and US will take part. Participants will be given either one of the EBX-102 capsules or a 'placebo' (a dummy pill with no active ingredient). Neither you nor the study team will know which treatment you are receiving, which helps make sure the results are fair.

Key takeaways

This study is for adults with Irritable Bowel Syndrome with Constipation (IBS-C).
It tests a new oral capsule (EBX-102) that aims to restore healthy gut bacteria.
Participants will receive either the study drug or a placebo for up to 18 weeks.
Regular clinic visits, diaries, and questionnaires are part of taking part.
Potential benefits include symptom improvement, but there's no guarantee.
Possible side effects include nausea, bloating, and stomach cramps.

Who may be eligible?

This study is looking for adults aged between 18 and 70 years old who have been diagnosed with Irritable Bowel Syndrome with Constipation (IBS-C). To be eligible, your IBS-C symptoms should be at least moderately severe, including regular tummy pain. You should also be having fewer than three complete bowel movements per week.

You also need to be willing to stop taking any other medicines or supplements for bowel problems (like probiotics) that aren't prescribed as part of the study for the duration of the trial. Generally, you should be in good overall health, without any recent serious bowel infections or other significant medical conditions. You'll also need to be able to come to the clinic for visits and follow the study instructions.

Quick self-check

Are you 18 to 70 years old?
Do you have a diagnosis of Irritable Bowel Syndrome with Constipation (IBS-C)?
Do you experience moderate to severe IBS-C symptoms, including tummy pain and fewer than 3 bowel movements per week?
Are you able to attend clinic visits and keep daily diaries?
Are you willing to stop other bowel medications/probiotics during the study?
Are you generally in good health, without recent serious infections or other major illnesses?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it will last for up to 18 weeks, and you'll have about six visits to the clinic during that time. Before starting treatment, there will be up to 4 weeks of screening to make sure you're suitable. Once on treatment, you'll take a single dose of eight capsules at four of these visits. You won't know if you're taking the study drug or a placebo, and neither will the study team.

During the study, you'll be asked to keep diaries every day to record your bowel habits and any side effects. You'll also fill out weekly questionnaires about your tummy pain and constipation, and monthly questionnaires about your IBS symptoms and how they affect your quality of life. At each clinic visit, the study team will check your symptoms, do a general health check, and a physical exam. You'll also be asked to provide stool (poo) samples a few times so researchers can see how the gut bacteria change and monitor your safety.

Potential risks and benefits

There's a chance that taking part in this study could help improve your IBS-C symptoms by restoring a healthier balance of gut bacteria, especially if you receive the active study drug. However, there's no guarantee that you will personally benefit from taking part. As with any study, there are some potential risks. Taking blood samples can sometimes cause minor bruising or discomfort. The study treatment could cause side effects like feeling sick, bloating, diarrhoea, vomiting, or stomach cramps, though these don't happen to everyone and usually get better quickly. Because the treatment involves gut bacteria, there's a very small risk of exposure to infections, but the study team has strict screening processes to make the treatment as safe as possible, and they will carefully monitor your health. There's also always a chance of unknown side effects. If you are pregnant or could become pregnant, there are additional risks to consider, and specific precautions will be discussed. You are free to withdraw from the study at any time.

Locations (5)

The Functional Gut Clinic (Manchester)
Manchester, England
The Functional Gut Clinic
London, England
The Functional Gut Clinic
Cambridge, England
University Hospital of North Durham
Durham, England
NIHR Commercial Research Delivery Centre: Newcastle
Newcastle upon Tyne, England

Common questions

What is IBS-C?

IBS-C stands for Irritable Bowel Syndrome with Constipation. It's a common condition that causes tummy pain, bloating, and difficulty going to the toilet (constipation).

What is EBX-102?

EBX-102 is the name of the new treatment being tested. It's an oral capsule containing dried healthy gut bacteria, designed to help balance the bacteria in your gut.

What is a 'placebo'?

A placebo is a 'dummy pill' that looks exactly like the study drug but contains no active ingredients. It helps researchers compare the real treatment's effects fairly.

How long will the study last?

The study itself will last for up to 18 weeks, including up to 4 weeks of initial screening before treatment begins.

What is a 'Phase II' study?

A Phase II study is an early stage of testing a new treatment. It mainly aims to find out if the treatment is safe and if it shows promise in helping the condition.

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.