University of Minnesota
Minneapolis, Minnesota, 55414, United States
Location status: Recruiting
NCT Number: NCT06058520
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 are currently three FDA-approved treatments for HS, including adalimumab, secukinumab, and bimekizumab, each with 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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Early Phase 1
Minneapolis, Minnesota, 55414, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients receive 2 capsules daily for one week followed by one capsule daily for 2 weeks. MTT capsules are derived from a single donor per patient.
The placebo consists of a mixture of trehalose and crystalline methylcellulose (Avicel) in 6:1 (w/w) ratio that is packaged in size 0 swedish orange capsules, which are then double encapsulated in size 00 natural colored capsules to make them visibly indistinguishable from encapsulated active product.
Time frame: Baseline, 6 weeks, 12 weeks
Percent donor engraftment based on Bayesian, community-wide, culture-independent microbial source tracking
Time frame: 6 weeks, 12 weeks
Change in skin taxonomic relative abundances and diversity indices (alpha and beta diversity) at 6 and 12 weeks compared to baseline (t- test and regression-analysis evaluating change overtime for two and three time points)
Time frame: 6 weeks, 12 weeks
Change in stool taxonomic relative abundances and diversity indices (alpha and beta diversity) at 6 and 12 weeks compared to baseline (t- test and regression-analysis evaluating change overtime for two and three time points)
Time frame: 12 weeks
Change in stool small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline
Time frame: 12 weeks
Change in serum small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline
Time frame: 6 weeks, 12 weeks
change in stool small molecule metabolites including kynurenine, tryptophan and sphingomyelins at 6 and 12 weeks compared to baseline
Time frame: 12 weeks
Physician-reported clinical response at 12 weeks compared to baseline measured by Hidradenitis Suppurativa Clinical Response (HiSCR)
Time frame: 12 weeks
Physician-reported clinical response at 12 weeks compared to baseline measured by International Hidradenitis Suppurativa Severity Score 55 (IHS4-55)
Time frame: 12 weeks
12 weeks compared to baseline
Time frame: 12 weeks
12 weeks compared to baseline
Time frame: 12 weeks
12 weeks compared to baseline
Time frame: 12 weeks
12 weeks compared to baseline
Time frame: 12 weeks
12 weeks compared to baseline
Time frame: 12 weeks
12 weeks compared to baseline
Time frame: 12 weeks
12 weeks compared to baseline
Contact information is provided by the study sponsor or research team.
University of Minnesota
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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