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Microbiota Therapy

Fecal Microbiota Transplant for Hidradenitis Suppurativa

Phase < 1

Recruiting

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Age >= 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 12 weeks

Awards & highlights

Study Summary

This trial looks into a new treatment for HS with only one FDA-approved option. It hopes to investigate if gut microbiome changes can improve HS, which significantly reduces quality of life & has high medical costs.

Who is the study for?

This trial is for adults over 18 with Hidradenitis Suppurativa (HS) diagnosed by a dermatologist. Participants must not be pregnant, planning pregnancy, or breastfeeding and should use effective birth control if applicable. They must speak English, have stable medication doses for 30 days prior to the study, and cannot have inflammatory bowel disease or recent major bowel surgery.Check my eligibility

What is being tested?

The trial tests whether capsule microbiota transplant therapy (MTT), which involves swallowing capsules containing freeze-dried gut bacteria, can improve HS by changing the gut microbiome. This pilot study compares MTT's effects against a placebo drug in influencing skin health through gut-derived metabolites.See study design

What are the potential side effects?

While specific side effects of MTT are not detailed here, similar treatments may cause gastrointestinal discomforts such as bloating or changes in bowel habits. Allergic reactions could occur but are monitored closely given that participants with severe food allergies are excluded.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am using effective birth control or am not able to have children.

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I am 18 years old or older.

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I have been diagnosed with hidradenitis suppurativa by a skin doctor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent donor engraftment

Secondary outcome measures

Change in Dermatology Life Quality Index (DLQI)

Change in Hidradenitis Suppurativa quality of life (HiSQOL)

Change in IHS4

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MMT groupExperimental Treatment1 Intervention

patients with HS randomized to receive MTT

Group II: Placebo groupPlacebo Group1 Intervention

patients with HS randomized to receive placebo treatment

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,381 Previous Clinical Trials

1,588,759 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are additional participants currently being accepted for this trial?

"The clinicaltrials.gov registry reveals that this trial, initially posted on October 1st 2023 and last updated on September 21st 2023, is no longer recruiting patients. Fortunately there are 40 other trials still actively looking for volunteers to participate in them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa

2023. "Capsule Microbiota Transplant Therapy for Hidradenitis Suppurativa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06058520.

All > Hidradenitis Suppurativa