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Microbiota Therapy
Fecal Microbiota Transplant for Hidradenitis Suppurativa
Phase < 1
Recruiting
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women who are not post-menopausal (at least 12 months of non-therapy induced amenorrhea) or surgically sterile (e.g. absence of ovaries and/or uterus) must remain abstinent or use a highly effective form of birth control (e.g. oral contraception, transdermal patch, barrier, intrauterine device). Periodic abstinence and early withdraw are not acceptable methods
Age >= 18 years of age
Must not have
History of inflammatory bowel disease
No active skin disease other than HS that could interfere with assessments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 12 weeks
Summary
This trial looks into a new treatment for HS with only one FDA-approved option. It hopes to investigate if gut microbiome changes can improve HS, which significantly reduces quality of life & has high medical costs.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects of MTT are not detailed here, similar treatments may cause gastrointestinal discomforts such as bloating or changes in bowel habits. Allergic reactions could occur but are monitored closely given that participants with severe food allergies are excluded.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am using effective birth control or am not able to have children.
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I am 18 years old or older.
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I have been diagnosed with hidradenitis suppurativa by a skin doctor.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of inflammatory bowel disease.
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I don't have any skin conditions that could affect study assessments, except for HS.
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I cannot or will not give my consent to participate.
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I have had a major surgery to remove a large part of my intestines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks, 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent donor engraftment
Secondary study objectives
Change in Dermatology Life Quality Index (DLQI)
Change in Hidradenitis Suppurativa quality of life (HiSQOL)
Change in IHS4
+11 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MMT groupExperimental Treatment1 Intervention
patients with HS randomized to receive MTT
Group II: Placebo groupPlacebo Group1 Intervention
patients with HS randomized to receive placebo treatment
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,439 Previous Clinical Trials
1,621,942 Total Patients Enrolled