Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

Official title:

Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06058520
• Other study ID #: Microbiota
• Status: Recruiting
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

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