Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06058520
Other study ID # Microbiota
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date October 1, 2023
Est. completion date January 1, 2025

Study information

Verified date May 2024
Source University of Minnesota
Contact Gretchen Bellefeuille
Phone 612-626-0249
Email belle116@umn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 16
Est. completion date January 1, 2025
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion 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. 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 - Able to comply to study measures in the opinion of the investigator. - Stable doses of all medications for 30 days prior to baseline Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fecal Microbiota - lyophilized
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.
Placebo drug
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.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent donor engraftment Percent donor engraftment based on Bayesian, community-wide, culture-independent microbial source tracking Baseline, 6 weeks, 12 weeks
Secondary Skin toxonomic relative abundances and diversity indices 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) 6 weeks, 12 weeks
Secondary Stool toxonomic relative abundances and diversity indices 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) 6 weeks, 12 weeks
Secondary Stool small chain fatty acids Change in stool small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline 12 weeks
Secondary Serum small chain fatty acids Change in serum small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline 12 weeks
Secondary Stool small molecule metabolites change in stool small molecule metabolites including kynurenine, tryptophan and sphingomyelins at 6 and 12 weeks compared to baseline 6 weeks, 12 weeks
Secondary Physician-reported clinical response 1 Physician-reported clinical response at 12 weeks compared to baseline measured by Hidradenitis Suppurativa Clinical Response (HiSCR) 12 weeks
Secondary Physician-reported clinical response 2 Physician-reported clinical response at 12 weeks compared to baseline measured by International Hidradenitis Suppurativa Severity Score 55 (IHS4-55) 12 weeks
Secondary Change in IHS4 12 weeks compared to baseline 12 weeks
Secondary Change in total draining tunnel count 12 weeks compared to baseline 12 weeks
Secondary Change in the Hidradenitis Suppurativa Activity and Severity Index 12 weeks compared to baseline 12 weeks
Secondary Change in Hidradenitis Suppurativa quality of life (HiSQOL) 12 weeks compared to baseline 12 weeks
Secondary Change in Dermatology Life Quality Index (DLQI) 12 weeks compared to baseline 12 weeks
Secondary Change in skin pain numerical rating scale (NRS) 12 weeks compared to baseline 12 weeks
Secondary Change in hidradenitis suppurativa patient global assessment 12 weeks compared to baseline 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT02904902 - Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa Phase 3
Completed NCT03628924 - A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS) Phase 2
Not yet recruiting NCT05531747 - Replicative Stress in Hair Follicle Stem Cells and Pathogeny of Hidradenitis Suppurativa N/A
Recruiting NCT06028230 - A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Phase 2
Completed NCT03275870 - Hydroxychloroquine for the Treatment of Hidradenitis Suppurativa Phase 1/Phase 2
Completed NCT03248531 - A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa. Phase 2
Withdrawn NCT04100083 - Spironolactone for Hidradenitis Suppurativa Phase 4
Completed NCT00329823 - Etanercept in Hidradenitis Suppurativa Phase 2
Recruiting NCT05710393 - Hidradenitis - an Analysis of Genetic Traits and Linkages in Families
Completed NCT04019041 - A Study to Evaluate the Efficacy, Safety and Tolerability of Bermekimab in Patients With Hidradenitis Suppurativa Phase 2
Completed NCT05286567 - A Double-blind Placebo-controlled Randomized Trial Evaluating the Efficacy and Safety of a Novel HSP90 Inhibitor (RGRN-305) in the Treatment of Moderate to Severe Hidradenitis Supppurativa. Phase 1
Withdrawn NCT03929835 - Study to Investigate the Efficacy and Safety of Cannabis Oil for the Treatment of Subjects With Hidradenitis Suppurativa Phase 2
Terminated NCT04325607 - Negative Pressure Wound Therapy With Instillation for Treatment of Hidradenitis Suppurativa N/A
Terminated NCT03238469 - Microwave Ablation in Mild Axillary Hidradenitis Suppurativa N/A
Completed NCT04449354 - HidraWear AX HS Study N/A
Recruiting NCT06123429 - Mindfulness in Hidradenitis Suppurativa N/A
Recruiting NCT05934825 - Clinical Trial to Evaluate Safety and Efficiency of Mesenchymal Stem Cell in Patients With Hidradenitis Suppurativa Phase 1/Phase 2
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Recruiting NCT06046729 - A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Phase 2
Recruiting NCT04246372 - Tofacitinib for Immune Skin Conditions in Down Syndrome Phase 2