RecruitingPHASE3INTERVENTIONAL

Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal

This research wants to find out if a treatment called Fecal Microbiota Transplantation (FMT), sometimes called a 'stool transplant', can help people with Crohn's disease. Specifically, it's for patients who are feeling well after taking anti-TNF medicines and are ready to stop them. Crohn's disease is a long-term condition that causes inflammation in the gut. While anti-TNF medicines are effective, they can have significant side effects and are costly. This study aims to see if FMT can act as a 'maintenance' treatment, meaning it helps keep Crohn's in remission (when symptoms are gone or much better) after anti-TNF medicines are stopped, by bringing back healthy gut bacteria.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

150

Start

22 Sep 2021

Estimated completion

22 Jul 2029

Crohn Disease

What is this study about?

Crohn's disease is a long-lasting condition where parts of your digestive system become inflamed. This can cause symptoms like tummy pain, diarrhoea, and tiredness. We don't fully understand why Crohn's happens, but it seems to involve your body's immune system reacting badly to the bacteria in your gut.

Many people with Crohn's take strong medicines called anti-TNFs to help control their symptoms. These medicines are effective but can be expensive and sometimes have serious side effects. Because of this, doctors are always looking for other ways to help patients, especially those who are doing well and might be able to stop their current treatment.

This study is looking at a treatment called Fecal Microbiota Transplantation, or FMT. This involves taking stool (poo) from a healthy donor and putting it into the gut of someone with Crohn's. The idea is that the healthy bacteria from the donor's stool might help rebalance the gut bacteria in people with Crohn's, helping them stay in remission after they stop their anti-TNF medicines. We are running a large study (Phase 3) to see if this treatment genuinely works.

Key takeaways

This study investigates FMT for Crohn's disease.
It aims to see if FMT helps maintain well-being after stopping anti-TNF drugs.
Participation involves stopping anti-TNFs and receiving either FMT or a placebo.
You will have regular check-ups over about a year.
This is a Phase 3 study, meaning it's a large trial to confirm effectiveness and safety.

Who may be eligible?

To join this study, people need to be between 18 and 74 years old and have been diagnosed with Crohn's disease for at least six months. An important part is that you must have been feeling well, without needing steroids or changes to your other Crohn's medicines, for at least six months while on anti-TNF treatment. You also need to be willing to stop your anti-TNF medicine as part of the study.

There are also some reasons why you might not be able to join. For example, if you've had surgery for Crohn's complications recently, have active problems around your back passage (anus), or have had a lot of your small bowel removed. If you are pregnant or breastfeeding, or are taking part in another medical study, you won't be able to participate.

Healthy people can also take part as stool donors, if they are between 18 and 49 years old, have a healthy body weight and regular bowel movements, and don't have certain health conditions. More detailed information about being a donor is available in the full study plan.

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 74 years old?
Have you been diagnosed with Crohn's disease for at least 6 months?
Have you been feeling well, without flares or changes to your Crohn's treatment, for at least the last 6 months while on an anti-TNF medicine?
Are you willing to stop your anti-TNF medicine as part of the study?
Are you not currently pregnant or breastfeeding, or planning to be during the study?
Have you not had complicated Crohn's surgery or an active problem around your back passage recently?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first have some health checks to make sure you are suitable. If you are, you will then stop your anti-TNF medication. You will receive either the FMT treatment or a sham (placebo) treatment, which looks the same but doesn't contain the active treatment. This is given through a procedure similar to a colonoscopy.

Over the next year, you will have regular visits to the hospital for checks, which may include blood tests, stool samples, and possibly further examinations of your gut. These visits are to monitor your Crohn's and see how you are responding to the treatment. The total duration of your participation in the study, from starting until your last follow-up, will be around a year.

Potential risks and benefits

Participating in this study might offer a potential benefit: if the FMT treatment works, it could help keep your Crohn's under control after stopping anti-TNF medicines, possibly reducing your need for strong drugs with their associated side effects. However, as with any medical procedure, there are potential risks, such as discomfort from the colonoscopy-like procedure or, less commonly, an infection or other reaction to the FMT. Your Crohn's disease could also get worse after stopping your anti-TNF medicine. You will be closely monitored throughout the study, and you are free to withdraw from the study at any time without giving a reason, and this decision will not affect your future medical care.

Locations (1)

Gastroenterology Department of Saint Antoine Hospital
Verified postcode
Paris, France· Recruiting

Common questions

What is Fecal Microbiota Transplantation (FMT)?

FMT is a procedure where stool (poo) from a healthy person is transferred into the gut of someone with a health condition, hoping to introduce healthy bacteria.

What are anti-TNF medicines?

Anti-TNF medicines are a type of strong drug used to reduce inflammation in conditions like Crohn's disease, but they can have side effects.

What does 'Phase 3' study mean?

A Phase 3 study is a large research study that compares a new treatment to existing treatments or a placebo to see how effective and safe it is before it can be widely used.

Will I know if I'm getting the real treatment or the placebo?

No, in this type of study (called 'blinded'), neither you nor your doctors will know if you're receiving the FMT or the placebo. This helps make the study results accurate.

What if my Crohn's symptoms return during the study?

You will be closely monitored, and if your Crohn's symptoms return or get worse, the study doctors will discuss the best treatment options with you, which may involve restarting your previous medications.

How to find out more

Harry SOKOL, PU-PH

harry.sokol@aphp.fr 01 49 28 31 62 Official trial record

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