Fecal Microbiota Transplant for Hidradenitis Suppurativa

Overseen By Gretchen Bellefeuille

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Minnesota

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Inflammatory bowel disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether fecal microbiota transplant, which uses healthy stool to adjust gut bacteria, can improve symptoms of hidradenitis suppurativa (HS), a painful skin condition that often affects daily life. Participants will receive either the actual microbiota transplant or a placebo drug (an inactive substance) to compare results. The trial focuses on how altering gut bacteria might impact the skin in those with HS. This trial may suit individuals diagnosed with HS who have maintained stable medication doses for at least 30 days. As an Early Phase 1 trial, the research seeks to understand how the treatment works in people, offering participants a chance to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial requires that you have stable doses of all medications for 30 days before starting, and you cannot use any topical or oral antibiotics within 30 days or oral antibiotics within 90 days of joining the study.

What prior data suggests that Fecal Microbiota Transplant is safe for Hidradenitis Suppurativa?

Research shows that fecal microbiota transplant (FMT) is under study for various health issues. This treatment transfers healthy bacteria from a donor's stool to balance the gut microbiome, the collection of tiny organisms living in the intestines.

Studies have shown that FMT is generally safe in the short term, meaning it usually doesn't cause problems immediately after treatment. However, limited information exists on its long-term safety, so researchers continue to explore any effects it might have over time.

An eight-year study from Hong Kong used FMT successfully for different conditions, but the long-term effects remain not fully understood.

Overall, FMT appears well-tolerated in the short term, but those interested should consider the limited long-term data. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for hidradenitis suppurativa, which often involve antibiotics, anti-inflammatory drugs, or biologics, fecal microbiota transplant (FMT) is unique because it targets the gut microbiome. Researchers are excited about this treatment because FMT aims to restore a healthy balance of gut bacteria, which could potentially reduce inflammation and improve skin health from the inside out. This approach could offer a new pathway to relief for patients, especially those who haven't responded well to conventional therapies. The idea of using the body's own microbiome to tackle this condition is a fresh and promising direction in medical research.

What evidence suggests that Fecal Microbiota Transplant could be an effective treatment for Hidradenitis Suppurativa?

Research shows that fecal microbiota transplant (FMT), which participants in this trial may receive, could be promising for treating Hidradenitis Suppurativa (HS). Although specific data on FMT for HS remains limited, FMT has successfully treated other conditions like Clostridium difficile infections. By introducing healthy bacteria to the gut, FMT helps balance the body's microbiome—the community of tiny organisms living within us. This balance might also improve skin health. Early findings suggest that altering gut bacteria could affect skin conditions like HS. While more research is needed, the potential of FMT to help people with HS presents an exciting area of study. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Hidradenitis Suppurativa (HS) diagnosed by a dermatologist. Participants must not be pregnant, planning pregnancy, or breastfeeding and should use effective birth control if applicable. They must speak English, have stable medication doses for 30 days prior to the study, and cannot have inflammatory bowel disease or recent major bowel surgery.

Inclusion Criteria

Able to comply to study measures in the opinion of the investigator.

I am using effective birth control or am not able to have children.

Able and willing to provide informed consent

Exclusion Criteria

I haven't taken any antibiotics in the last 30 days.

I have a history of inflammatory bowel disease.

I haven't had major bowel surgery in the last 4 weeks and don't plan any during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either microbiota transplant therapy (MTT) or placebo

12 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fecal Microbiota
• Placebo drug

Trial Overview The trial tests whether capsule microbiota transplant therapy (MTT), which involves swallowing capsules containing freeze-dried gut bacteria, can improve HS by changing the gut microbiome. This pilot study compares MTT's effects against a placebo drug in influencing skin health through gut-derived metabolites.

How Is the Trial Designed?

Group I: MMT group Experimental Treatment 1 Intervention

patients with HS randomized to receive MTT

Group II: Placebo group Placebo Group 1 Intervention

patients with HS randomized to receive placebo treatment

Fecal Microbiota is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Fecal Microbiota Transplantation for:

• Recurrent Clostridioides difficile (C. diff) infection

Approved in European Union as Fecal Microbiota Transplantation for:

• Recurrent Clostridioides difficile (C. diff) infection

Approved in Canada as Fecal Microbiota Transplantation for:

• Recurrent Clostridioides difficile (C. diff) infection

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

A study involving 123 patients who underwent fecal microbiota transplantation (FMT) over a median follow-up of 30.3 months showed that FMT has an excellent long-term safety profile, with new medical conditions being unlikely to be related to the procedure.

In patients with recurrent Clostridioides difficile infection, FMT was associated with a significantly higher survival probability compared to those treated with antibiotics, indicating its efficacy in improving long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Safety Outcomes of Fecal Microbiota Transplantation: Real-World Data Over 8 Years From the Hong Kong FMT Registry. Yau, YK., Lau, LHS., Lui, RNS., et al.[2023]

Fecal microbiota transplantation (FMT) is highly effective for treating Clostridium difficile infection (CDI), with a 90% resolution of diarrhea reported in 867 patients across 33 studies, and a 94% resolution after repeated FMT in a randomized controlled trial with 16 participants.

FMT shows promise in treating ulcerative colitis, with remission rates varying from 0% to 68% in 106 patients, while its efficacy in Crohn's disease, chronic constipation, pouchitis, and irritable bowel syndrome remains inconclusive due to limited data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. Rossen, NG., MacDonald, JK., de Vries, EM., et al.[2022]

Fecal microbiota transplantation (FMT) was performed on 26 patients with recurrent Clostridium difficile infection, showing a 92% success rate in preventing further diarrhea or CDI relapse over a follow-up period of up to 30 months.

The procedure was found to be simple and safe, with most patients remaining free of significant diarrhea after the treatment, highlighting FMT as a promising alternative to prolonged antibiotic courses for managing recurrent CDI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation for relapsing Clostridium difficile infection in 26 patients: methodology and results. Kelly, CR., de Leon, L., Jasutkar, N.[2022]

In a study involving 9 patients with moderate to severely active ulcerative colitis (UC), 77.8% achieved a clinical response within 2 weeks after fecal microbiota transplantation (FMT), indicating its short-term efficacy as a treatment.

FMT was found to be safe, with only mild and self-limiting adverse events reported in 33.3% of patients, and the method of delivery (nasojejunal tube vs. transendoscopic enteral tubing) did not significantly affect clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of fecal microbiota transplantation by washed preparation in patients with moderate to severely active ulcerative colitis. Chen, M., Liu, XL., Zhang, YJ., et al.[2021]

In a study of 124 patients receiving Faecal Microbiota Transplant (FMT) for recurrent or refractory Clostridioides difficile infection (CDI), the clinical response rate was 83.9% after one treatment, indicating FMT is highly effective.

The successful licensing of FMT as a medicinal product in the UK has improved its availability through stool banks, ensuring safe and quality-assured treatments for patients with CDI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results from the first English stool bank using faecal microbiota transplant as a medicinal product for the treatment of Clostridioides difficile infection. McCune, VL., Quraishi, MN., Manzoor, S., et al.[2022]

The study demonstrated that daily oral administration of frozen encapsulated fecal microbiota transplantation (cFMT) is safe and well-tolerated in patients with mild to moderate ulcerative colitis (UC), with no treatment-related adverse events reported.

Two out of six subjects receiving cFMT achieved clinical remission, suggesting that cFMT may help maintain beneficial changes in gut microbiota and improve clinical outcomes, although further research is needed to confirm these findings and address home storage issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily, oral FMT for long-term maintenance therapy in ulcerative colitis: results of a single-center, prospective, randomized pilot study. Crothers, JW., Chu, ND., Nguyen, LTT., et al.[2022]

In 2019, 31 FMT centers across 17 European countries performed a total of 1,874 fecal microbiota transplants, primarily for Clostridioides difficile infection (CDI), indicating that FMT is a common treatment for this condition.

Despite the high safety standards and adherence to guidelines observed in these centers, only about 10% of the estimated patients needing FMT for recurrent CDI in Europe received the treatment, highlighting a significant gap in coverage and the need for increased clinical awareness and activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of Faecal Microbiota Transplantation (FMT) in Europe: A Europe-wide survey. Baunwall, SMD., Terveer, EM., Dahlerup, JF., et al.[2022]

Fecal microbiota transplantation (FMT) demonstrated high efficacy, particularly for recurrent Clostridium Difficile infection (RCDI) with an 85.2% clinical cure rate, while also showing effectiveness for other gastrointestinal disorders such as constipation and ulcerative colitis.

The study involved 406 patients and found no serious adverse events associated with FMT, although common side effects included respiratory discomfort and increased venting, which resolved shortly after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy analysis of fecal microbiota transplantation in the treatment of 406 cases with gastrointestinal disorders]. Li, N., Tian, H., Ma, C., et al.[2020]

Fecal microbiota transplantation (FMT) is recommended for treating recurrent Clostridium difficile infections and has shown benefits for various gastrointestinal disorders, but safety data is still limited due to the rapid adoption of the technique without extensive long-term studies.

Capsulized FMT therapy offers a promising solution for long-term maintenance and reduces the need for invasive procedures, indicating a shift towards safer and more tolerable methods of delivering FMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current research progress and thinking of fecal microbiota transplantation for the treatment of gastrointestinal disorders]. Li, N., Tian, H.[2020]

In a study comparing fecal microbiota transplantation (FMT) protocols for recurrent Clostridioides difficile infection (rCDI), a higher volume of fresh fecal filtrate (30-50 g) resulted in a significantly higher clinical success rate (98%) compared to a lower volume of frozen fecal preparation (22.7 g) which had a success rate of 64%.

Overall clinical success was achieved in 100% of patients receiving fresh fecal filtrate at Center B, while 86% of patients at Center A achieved success after potentially needing repeat FMTs, indicating that the method and amount of fecal material used in FMT can greatly impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superiority of Higher-Volume Fresh Feces Compared to Lower-Volume Frozen Feces in Fecal Microbiota Transplantation for Recurrent Clostridioides Difficile Colitis. Agarwal, A., Maheshwari, A., Verma, S., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06058520

Capsule Microbiota Transplant Therapy for Hidradenitis ... Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa ... Drug : Fecal Microbiota - lyophilized; Drug : Placebo drug. Other Study ID Numbers.

2. withpower.com withpower.com/trial/early-phase-1-hidradenitis-suppurativa-9-2023-3ac4c

Fecal Microbiota Transplant for Hidradenitis Suppurativa What data supports the effectiveness of the treatment Fecal Microbiota Transplant for Hidradenitis Suppurativa? ... Faecal Microbiota Transplant (FMT) for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8034505/

Fecal Microbiota Transplantation Is Highly Effective in Real ... A systematic review of the efficacy and safety of fecal microbiota transplant for Clostridium difficile infection in immunocompromised patients. Can J ...

4. experts.umn.edu experts.umn.edu/en/projects/capsule-fecal-microbiota-transplant-for-hidradenitis-suppurativa

Capsule Fecal Microbiota Transplant for Hidradenitis ... Description. Capsule Fecal Microbiota Transplant for Hidradenitis Suppurativa. Status, Active. Effective start/end date, 7/1/23 → 6/30/26. Funding. HIDRADENITIS ...

5. mdpi.com mdpi.com/2077-0383/11/14/4119

Fecal Microbiota Transplantation as New Therapeutic ... ... Intestinal Microbial Diversity Following Fecal ... efficacy of faecal microbiota transplant in a paediatric Crohn's disease population: PediCRaFT Trial.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11464302/

Safety and efficacy of fecal microbiota transplantation (FMT ... Long-term safety outcomes of fecal microbiota transplantation: real-world data over 8 years from the hong kong FMT registry. Clin Gastroenterol Hepatology ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0896841123000434

The role of faecal microbiota transplantation in chronic ... This review aims to give an overview of mechanisms of efficacy of FMT in chronic noncommunicable disorders, and paint the current landscape of its investigation ...