Clinical trial for Hidradenitis Suppurativa
Official title Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa
ClinicalTrials.gov ID: NCT06058520
What this study is testing
What is Fecal Microbiota - lyophilized?
This is an investigational oral capsule being studied as a potential treatment for hidradenitis suppurativa. It is designed to alter the gut microbiome, which may influence skin health through metabolites absorbed into the body.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether an oral microbiota transplant can change the gut bacteria and help improve skin symptoms in people with Hidradenitis Suppurativa.
- Who it's for
- You may be able to join if you have Hidradenitis Suppurativa and are looking for new treatment options.
- What's involved
- You would take a capsule at home each day. The study team will check your health with visits and ask about any side effects.
- Time commitment
- The study lasts about 6 months, with a few visits to the clinic for check‑ins.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Able and willing to provide informed consent
- English speaking
- Age \>= 18years of age
- Diagnosis of hidradenitis suppurativa by a dermatologist
- Women who are not post-menopausal (at least 12 months of non-therapy induced amenorrhea) or surgically sterile (e.g.
You likely can't join if
- Non-English speaking
- Refusal or inability to provide informed consent
- Planning on moving within 6 months from start of study
- Allergy to neomycin or vancomycin
- Anaphylactic food allergies
- Pregnancy, breastfeeding or planning pregnancy during study period (negative pregnancy test needed for persons of childbearing potential)
See the full eligibility criteria
- Able and willing to provide informed consent
- English speaking
- Age \>= 18years of age
- Diagnosis of hidradenitis suppurativa by a dermatologist
- Women who are not post-menopausal (at least 12 months of non-therapy induced amenorrhea) or surgically sterile (e.g.
- Able to comply to study measures in the opinion of the investigator.
- Stable doses of all medications for 30 days prior to baseline
- Non-English speaking
- Refusal or inability to provide informed consent
- Planning on moving within 6 months from start of study
- Allergy to neomycin or vancomycin
- Anaphylactic food allergies
- Pregnancy, breastfeeding or planning pregnancy during study period (negative pregnancy test needed for persons of childbearing potential)
- Use of any topical or oral antibiotics within 30 days of randomization
- Use of any oral antibiotics within 90 days of randomization
- History of inflammatory bowel disease
- Extensive bowel resection (e.g., subtotal colectomy, substantial removal of small bowel)
- No major bowel surgery within 4 weeks prior to baseline or planned major surgery during the study period
- No active skin disease other than HS that could interfere with assessments
The study team makes the final eligibility decision.
Where it is enrolling
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Minneapolis, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.