AuthorisedTherapeutic exploratory (Phase II)Interventional

FESTIVAL_Fecal transplantation in Hidradenitis suppurativa : a pilot study

This study, called FESTIVAL, is exploring if a treatment called a faecal transplant (FMT) can help people living with hidradenitis suppurativa (HS). HS is a skin condition that causes painful lumps, boils, and scarring. The study will involve transplanting healthy gut bacteria from a donor into people with HS. Researchers will be carefully observing if this treatment leads to an improvement in HS symptoms, such as the number and size of lumps, boils, and tunnels under the skin, over a 12-week period. They will also look at whether it helps with pain, quality of life, and the flow of discharge, and monitor for any side effects.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

University Hospital Of Clermont-Ferrand

Enrolment target

Start

24 Jun 2025

Hidrdenitis suppurative

What is this study about?

This study, called FESTIVAL, is looking into a new way to treat hidradenitis suppurativa (HS). HS is a chronic skin condition that causes painful and often deep lumps, boils, and tunnels (called fistulas) under the skin. It can be very uncomfortable and affect daily life. Current treatments exist, but researchers are always looking for better options.

This particular study is focusing on something called a "faecal transplant," often shortened to FMT. In simple terms, this means taking healthy gut bacteria from a healthy donor and putting it into the gut of someone with HS. The idea behind this is that the balance of bacteria in our gut can play a role in various health conditions, and by introducing healthy bacteria, it might help improve HS symptoms. This is a "pilot study," which means it's one of the first studies of its kind for HS, helping researchers decide if this approach is promising enough for larger studies in the future.

The main goal is to see if a faecal transplant can significantly reduce HS symptoms — specifically, if symptoms improve by at least 55% over 12 weeks. Researchers will measure this using a special scoring system that looks at the number of lumps, boils, and tunnels. They will also check for other benefits like reduced pain, improved quality of life, and fewer issues with skin discharge, while also keeping a close eye on any possible side effects, as patient safety is always the top priority.

Key takeaways

This study explores a new treatment for hidradenitis suppurativa (HS) using faecal transplant (FMT).
It aims to see if FMT can significantly reduce HS symptoms like lumps and pain.
Researchers will monitor participants for 24 weeks, checking for both benefits and side effects.
This is an early-stage 'pilot' study to gather initial information.
Participants must be 18 years or older and have HS.

Who may be eligible?

To be able to join this study, you need to be an adult, aged 18 years or older, as the study is open to both men and women. The researchers want to include a wide range of adults with hidradenitis suppurativa to see how the treatment might work for different people.

More detailed rules about who can and cannot join, such as your specific health history or other medications you might be taking, will be discussed by the study team. These rules are put in place to help make sure the study is safe for you and that the results are clear and reliable. If you're interested, the study team will go through all the requirements with you.

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 18 years or older?
Do you have hidradenitis suppurativa (HS)?
Are you able to attend study visits for assessments over 24 weeks?
Do you understand that this is a research study and not a guaranteed treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive a faecal transplant (FMT). The main goal is to see how your hidradenitis suppurativa (HS) symptoms change over 12 weeks after the transplant. You would have assessments at the start of the study, at 12 weeks, and again at 24 weeks. These assessments will involve measuring your HS symptoms using a special score, checking your pain and discharge levels, and asking about your quality of life. Researchers will also collect stool samples at the beginning and at 12 weeks to look at your gut bacteria. Any side effects you experience will be carefully monitored and reported for up to 6 months. The total duration of active follow-up for your symptoms will be 24 weeks, though side effects will be watched for longer.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as an improvement in your hidradenitis suppurativa symptoms, including a reduction in lumps, abscesses, and pain. However, as this is a new approach for HS, there's no guarantee it will improve your condition. There are potential risks associated with faecal transplantation, such as temporary stomach discomfort, changes in bowel habits, or very rarely, more serious gut issues or infections. All participants will be closely monitored for any side effects. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is a faecal transplant (FMT)?

A faecal transplant (FMT) involves taking stool (poo) from a healthy donor and putting it into your gut to introduce healthy bacteria. It's being studied to see if it can help balance gut bacteria and improve certain health conditions.

What is hidradenitis suppurativa (HS)?

Hidradenitis suppurativa (HS) is a long-term skin condition that causes painful lumps, boils, and tunnels under the skin, often in areas where skin rubs together like the armpits or groin.

What will researchers be looking for in this study?

The main thing they're looking for is at least a 55% improvement in your HS symptoms (like fewer lumps and boils) 12 weeks after the faecal transplant. They'll also check for improvements in pain and quality of life.

Will I need to take other medications during the study?

The study team will discuss all existing and new medications with you to ensure they don't interfere with the study's results or your safety. Specific rules about other medications will be explained fully if you consider joining.

What does 'pilot study' mean?

A pilot study is a small, early-stage study designed to see if a treatment is safe and shows enough promise to be investigated in larger, more extensive studies later on.