Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

Early Phase 1RecruitingNCT06058520

University of Minnesota16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hidradenitis Suppurativa

Interventions

Placebo drugDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percent donor engraftment

Percent donor engraftment based on Bayesian, community-wide, culture-independent microbial source tracking

Time frame: Baseline, 6 weeks, 12 weeks

Secondary Outcomes

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)

Time frame: 6 weeks, 12 weeks

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)

Time frame: 6 weeks, 12 weeks

Stool small chain fatty acids

Change in stool small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline

Time frame: 12 weeks

Serum small chain fatty acids

Change in serum small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline

Time frame: 12 weeks

Stool small molecule metabolites

change in stool small molecule metabolites including kynurenine, tryptophan and sphingomyelins at 6 and 12 weeks compared to baseline

Time frame: 6 weeks, 12 weeks

Physician-reported clinical response 1

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 2

Physician-reported clinical response at 12 weeks compared to baseline measured by International Hidradenitis Suppurativa Severity Score 55 (IHS4-55)

Time frame: 12 weeks

Change in IHS4

12 weeks compared to baseline

Time frame: 12 weeks

Change in total draining tunnel count

12 weeks compared to baseline

Time frame: 12 weeks

Change in the Hidradenitis Suppurativa Activity and Severity Index

12 weeks compared to baseline

Time frame: 12 weeks

Change in Hidradenitis Suppurativa quality of life (HiSQOL)

12 weeks compared to baseline

Time frame: 12 weeks

Change in Dermatology Life Quality Index (DLQI)

12 weeks compared to baseline

Time frame: 12 weeks

Change in skin pain numerical rating scale (NRS)

12 weeks compared to baseline

Time frame: 12 weeks

Change in hidradenitis suppurativa patient global assessment

12 weeks compared to baseline

Time frame: 12 weeks

Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts