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Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

Primary Purpose

Hidradenitis Suppurativa

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fecal Microbiota - lyophilized
Placebo drug
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MMT group

Placebo group

Arm Description

patients with HS randomized to receive MTT

patients with HS randomized to receive placebo treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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)
Stool small chain fatty acids
Change in stool small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline
Serum small chain fatty acids
Change in serum small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline
Stool small molecule metabolites
change in stool small molecule metabolites including kynurenine, tryptophan and sphingomyelins at 6 and 12 weeks compared to baseline
Physician-reported clinical response 1
Physician-reported clinical response at 12 weeks compared to baseline measured by Hidradenitis Suppurativa Clinical Response (HiSCR)
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)
Change in IHS4
12 weeks compared to baseline
Change in total draining tunnel count
12 weeks compared to baseline
Change in the Hidradenitis Suppurativa Activity and Severity Index
12 weeks compared to baseline
Change in Hidradenitis Suppurativa quality of life (HiSQOL)
12 weeks compared to baseline
Change in Dermatology Life Quality Index (DLQI)
12 weeks compared to baseline
Change in skin pain numerical rating scale (NRS)
12 weeks compared to baseline
Change in hidradenitis suppurativa patient global assessment
12 weeks compared to baseline

Full Information

First Posted
September 11, 2023
Last Updated
October 6, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT06058520
Brief Title
Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa
Official Title
Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MMT group
Arm Type
Experimental
Arm Description
patients with HS randomized to receive MTT
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
patients with HS randomized to receive placebo treatment
Intervention Type
Drug
Intervention Name(s)
Fecal Microbiota - lyophilized
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo drug
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent donor engraftment
Description
Percent donor engraftment based on Bayesian, community-wide, culture-independent microbial source tracking
Time Frame
Baseline, 6 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Skin toxonomic relative abundances and diversity indices
Description
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
Title
Stool toxonomic relative abundances and diversity indices
Description
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
Title
Stool small chain fatty acids
Description
Change in stool small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline
Time Frame
12 weeks
Title
Serum small chain fatty acids
Description
Change in serum small chain fatty acids (butyrate, acetate and propionate) at 12 weeks compared to baseline
Time Frame
12 weeks
Title
Stool small molecule metabolites
Description
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
Title
Physician-reported clinical response 1
Description
Physician-reported clinical response at 12 weeks compared to baseline measured by Hidradenitis Suppurativa Clinical Response (HiSCR)
Time Frame
12 weeks
Title
Physician-reported clinical response 2
Description
Physician-reported clinical response at 12 weeks compared to baseline measured by International Hidradenitis Suppurativa Severity Score 55 (IHS4-55)
Time Frame
12 weeks
Title
Change in IHS4
Description
12 weeks compared to baseline
Time Frame
12 weeks
Title
Change in total draining tunnel count
Description
12 weeks compared to baseline
Time Frame
12 weeks
Title
Change in the Hidradenitis Suppurativa Activity and Severity Index
Description
12 weeks compared to baseline
Time Frame
12 weeks
Title
Change in Hidradenitis Suppurativa quality of life (HiSQOL)
Description
12 weeks compared to baseline
Time Frame
12 weeks
Title
Change in Dermatology Life Quality Index (DLQI)
Description
12 weeks compared to baseline
Time Frame
12 weeks
Title
Change in skin pain numerical rating scale (NRS)
Description
12 weeks compared to baseline
Time Frame
12 weeks
Title
Change in hidradenitis suppurativa patient global assessment
Description
12 weeks compared to baseline
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irmina Wallander
Phone
(612) 624-5721
Email
wall0396@umn.edu
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irmina Wallander
Phone
612-624-5721
Email
wall0396@umn.edu
First Name & Middle Initial & Last Name & Degree
Noah Goldfarb, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

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