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Study on Fecal Microbiota Transplantation and Amoxicillin-Clavulanic Acid for Patients with Moderate to Severe Hidradenitis Suppurativa

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a skin condition called Hidradenitis Suppurativa, which is a chronic inflammatory disease that causes painful lumps under the skin. The study will explore a treatment involving a combination of antibiotics and a procedure known as Fecal Microbiota Transplantation (FMT). The antibiotics used in this study are amoxicillin-clavulanic acid, which are commonly used to treat bacterial infections. FMT involves transferring stool from a healthy donor to the patient to help restore a healthy balance of bacteria in the gut.

The purpose of the study is to evaluate how effective this treatment is in reducing the activity of the disease. Participants will first receive the antibiotic treatment, followed by the FMT. The study will monitor changes in the condition over a period of 12 weeks after the FMT. The goal is to see if there is an improvement in the number of painful lumps and other symptoms associated with the disease.

Throughout the study, participants will be assessed for improvements in their condition, including a reduction in the number of lumps and an improvement in their quality of life. The study will also track any side effects that may occur. By the end of the study, researchers hope to determine if this treatment approach can provide significant relief for those suffering from moderate to severe Hidradenitis Suppurativa.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, language proficiency, and medical history related to hidradenitis suppurativa (HS).

    The assessment ensures the presence of moderate to severe HS with specific characteristics, such as at least four inflammatory lesions.

  2. Step 2

    Antibiotic treatment

    Participants receive an antibiotic treatment with amoxicillin-clavulanic acid to manage HS symptoms. The duration of this treatment is determined by the study protocol.

  3. Step 3

    Fecal microbiota transplantation (FMT)

    Following the antibiotic treatment, participants undergo a procedure called fecal microbiota transplantation (FMT). This involves the introduction of healthy bacteria into the gut to help manage HS symptoms.

    The FMT is administered as a suspension injection.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for improvements in HS symptoms, such as a reduction in nodules, abscesses, and fistulas. This is measured using the IHS4 score at 12 weeks after FMT.

    Additional assessments occur at 24 weeks post-FMT to evaluate long-term effects.

  5. Step 5

    Evaluation of side effects

    Throughout the study, any side effects, such as abdominal pain or digestive issues, are recorded and analyzed.

    Participants are encouraged to report any adverse events they experience during the study period.

  6. Step 6

    Microbiota analysis

    The study includes an analysis of the fecal microbiota of both participants and donors. This involves sequencing specific genes to understand the bacterial composition before and after FMT.

Who can join the trial?

4 criteria

  • Patients must be 18 years or older.
  • Patients must have Hidradenitis Suppurativa (HS) with moderate to very severe symptoms. This means having at least 4 inflamed areas such as lumps, pus-filled pockets, or open sores.
  • Patients must have experienced at least one return of symptoms after completing a recommended medical treatment. This treatment includes taking a broad-spectrum antibiotic for 15 to 21 days, followed by a preventive treatment with either doxycycline or cotrimoxazole. A return of symptoms is defined as a new outbreak within 3 months after starting the treatments.
  • Patients must be able to speak and understand French.

Who cannot join the trial?

5 criteria

  • Patients who are not diagnosed with Hidradenitis Suppurativa cannot participate. This is a skin condition that causes small, painful lumps under the skin.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are not experiencing moderate to severe symptoms of the condition cannot participate. The study focuses on those with more intense symptoms.
  • Patients who have not followed treatment according to French recommendations cannot participate. This means they must have tried specific treatments before joining the study.
  • Patients who are part of a vulnerable population cannot participate. This includes groups that may need special protection or care.
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Investigated drugs

  • Amoxicillin-Clavulanic Acid

    is a combination antibiotic used to treat infections caused by bacteria. In this trial, it is used to help reduce the activity of a skin condition called Hidradenitis suppurativa. This condition causes painful lumps under the skin, and the antibiotic helps by fighting the bacteria that might be contributing to these symptoms.

  • Fecal Microbiota Transplantation (FMT)

    is a procedure where stool from a healthy donor is placed into the gut of a patient. The goal is to introduce healthy bacteria into the patient's digestive system. In this trial, FMT is used after the antibiotic treatment to help improve the skin condition by restoring a healthy balance of bacteria in the body.

What is already known about the treatment

Amoxicillin-Clavulanic Acid – This medication is administered orally in the form of tablets or liquid and is used to treat bacterial infections. In the context of the clinical trial, it is being evaluated for its effectiveness in treating Hidradenitis Suppurativa, a skin condition characterized by painful lumps under the skin. The medication works by combining amoxicillin, which kills bacteria, with clavulanic acid, which prevents bacteria from becoming resistant to amoxicillin. It is classified as an antibiotic and is commonly used to treat various infections caused by bacteria.

Investigated diseases

Hidradenitis suppurativa – Hidradenitis suppurativa is a chronic skin condition characterized by the formation of painful nodules, abscesses, and fistulas, primarily in areas where skin rubs together, such as the armpits, groin, and under the breasts. The disease progresses through recurrent episodes of inflammation, leading to the development of new lesions and the potential for scarring. Over time, these lesions can become interconnected through tunnels under the skin, known as sinus tracts. The condition often begins after puberty and can persist for many years, with periods of flare-ups and remission. The severity of the disease can vary widely among individuals, with some experiencing mild symptoms and others facing more extensive skin involvement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519003-99-00Protocol codeRBHP 2023 BUISSONEstimated enrolment24 patientsSponsorUniversity Hospital Of Clermont-Ferrand

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