Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

Study Overview
=================
Brief 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.

Official Title
-----------------
Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

Conditions
-----------------
Hidradenitis Suppurativa

Intervention / Treatment
-----------------
* Drug: Fecal Microbiota - lyophilized
* Drug: Placebo drug


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is an exploratory, randomized, double blind, placebo- controlled clinical trial. Subjects and investigators will be blinded to the Microbiota transplant therapy (MTT) and placebo arms.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MMT group<br>patients with HS randomized to receive MTT | Drug: Fecal Microbiota - lyophilized<br>* 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.<br>|
| Placebo Comparator: Placebo group<br>patients with HS randomized to receive placebo treatment | Drug: Placebo drug<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent donor engraftment | Percent donor engraftment based on Bayesian, community-wide, culture-independent microbial source tracking | Baseline, 6 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Stool small chain fatty acids | Change in stool small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline | 12 weeks | 
| Serum small chain fatty acids | Change in serum small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline | 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 | 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) | 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) | 12 weeks | 
| Change in IHS4 | 12 weeks compared to baseline | 12 weeks | 
| Change in total draining tunnel count | 12 weeks compared to baseline | 12 weeks | 
| Change in the Hidradenitis Suppurativa Activity and Severity Index | 12 weeks compared to baseline | 12 weeks | 
| Change in Hidradenitis Suppurativa quality of life (HiSQOL) | 12 weeks compared to baseline | 12 weeks | 
| Change in Dermatology Life Quality Index (DLQI) | 12 weeks compared to baseline | 12 weeks | 
| Change in skin pain numerical rating scale (NRS) | 12 weeks compared to baseline | 12 weeks | 
| Change in hidradenitis suppurativa patient global assessment | 12 weeks compared to baseline | 12 weeks |