Fecal Microbiota Transplant for Hidradenitis Suppurativa

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of Minnesota

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Inflammatory bowel disease, others

Trial Summary

What is the purpose of this trial?

HS is relatively common in the United States with a prevalence of 0.1-1.0%. 1 HS has a dramatic impact on quality of life, significantly more so than other chronic skin diseases, such as psoriasis or atopic dermatitis (AD). HS also has a large economic impact, due to frequent emergency department and inpatient care utilization, and re-hospitalization rates similar to congestive heart failure. Unfortunately, few treatment options are effective. There is only one currently FDA-approved treatment, adalimumab, but only 40- 60% respond to treatment and over 50% lose response within one year . The overarching goal of this pilot study is to investigate the central hypothesis that oral microbiota transplant therapy(MTT) alters the gut microbiome in patients with Hidradenitis Suppurativa (HS), influencing cutaneous microbiota via systemically absorbed gut-derived metabolites.

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 data supports the effectiveness of the treatment Fecal Microbiota Transplant for Hidradenitis Suppurativa?

Fecal Microbiota Transplantation (FMT) has shown effectiveness in treating recurrent Clostridioides difficile infections, with improved outcomes compared to antibiotics. This suggests potential benefits of FMT in altering gut bacteria to help with other conditions, although specific data for Hidradenitis Suppurativa is not available. ^{1 2 3 4 5}

Is fecal microbiota transplantation (FMT) generally safe for humans?

Fecal microbiota transplantation (FMT) has been used for various conditions, and while short-term safety data is available, long-term safety data is limited. Some potential short-term side effects are related to the method of delivery, such as colonoscopy or sedation, but more research is needed to fully understand long-term safety. ^{1 2 6 7 8}

How is fecal microbiota transplantation (FMT) different from other treatments for hidradenitis suppurativa?

FMT is unique because it involves transferring healthy bacteria from a donor's stool to a patient's gut, aiming to restore a balanced microbiome, which is different from traditional treatments that might focus on antibiotics or surgery. This approach is novel for hidradenitis suppurativa, as it targets the gut microbiome rather than directly treating skin symptoms. ^{1 2 4 9 10}

Research Team

Eligibility Criteria

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.

English speaking

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.

Trial Timeline

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

Treatment Details

Interventions

• Fecal Microbiota (Microbiota Therapy)
• Placebo drug (Other)

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.

Participant Groups

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 Canada for the following indications:

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+

Shashank Priya

University of Minnesota

Chief Executive Officer since 2023

PhD in Materials Engineering from Penn State

Charles Semba

University of Minnesota

Chief Medical Officer since 2021

MD from the University of Minnesota Medical School

Findings from Research

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]

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]

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 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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The use of Faecal Microbiota Transplantation (FMT) in Europe: A Europe-wide survey. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Efficacy and safety of fecal microbiota transplantation by washed preparation in patients with moderate to severely active ulcerative colitis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation for relapsing Clostridium difficile infection in 26 patients: methodology and results. [2022]

4. England 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. [2022]

5. United States 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. [2022]

7. United States 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. [2023]

8. China pubmed.ncbi.nlm.nih.gov

[Current research progress and thinking of fecal microbiota transplantation for the treatment of gastrointestinal disorders]. [2020]

9. China pubmed.ncbi.nlm.nih.gov

[Efficacy analysis of fecal microbiota transplantation in the treatment of 406 cases with gastrointestinal disorders]. [2020]

10. England 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. [2022]