Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata

Launched by UNIVERSITY OF MINNESOTA · Dec 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Microbiota Transplant Therapy (MTT) for patients with Alopecia Areata (AA), a condition that causes patchy hair loss. The goal is to see if this therapy can help restore hair growth by analyzing the effects on the skin and gut bacteria, as well as the immune system. The trial will look at how the gut microbiome might relate to the condition and its treatment response, helping researchers understand more about how to effectively treat AA.

To participate in the trial, individuals must be between 18 and 75 years old and have moderate to severe AA, which means they have significant hair loss that has persisted for at least three months. Participants should not have any active hair regrowth at the start of the study and need to meet certain health criteria. If eligible, participants can expect to undergo various tests and evaluations, including blood samples and skin biopsies, to help researchers gather important information about their condition and how the new treatment works. It's also important to note that participants cannot be on certain medications or have specific health issues that might interfere with the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients 18 to 75 years of age with moderate to severe alopecia areata (SALT score \>30%).
• • Patients with a diagnosis of patch type alopecia areata, totalis, or universalis..
• • Duration of hair loss \>=3 months..
• • No evidence of active, ongoing regrowth present at baseline.
• • Females of childbearing potential must have a negative urine or serum pregnancy test at screening and immediately prior to MTT.
• • Females of childbearing potential must agree to use an effective form of contraception from 14 days prior to study antibiotics through at least 30 days after MTT. Acceptable forms of contraception include oral or intramuscular contraceptives, intrauterine devices, surgical sterilization.
• • Participants are not enrolled in another clinical study.
• • If undergoing treatment with a JAK inhibitor, participant is willing to discontinue treatment for 1 month prior to enrollment and throughout the duration of the study.
• Exclusion Criteria:
• • Active gastrointestinal infection at time of enrollment.
• • Having been administered antibiotics in the last 48 hours.
• • Patients will be eligible to enroll if antibiotic therapy is discontinued for at minimum 48 hours prior to treatment..
• • Requires continued antibiotic use
• • Allergy to study antibiotics (vancomycin, neomycin).
• • Known or suspected severe gastrointestinal dysmotility disorder, e.g., gastroparesis, pseudo-obstruction, scleroderma with gastrointestinal involvement
• • Ileus or small bowel obstruction.
• • Major gastrointestinal surgery (e.g., significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy.
• • History of total colectomy.
• • Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy.
• • Unable or unwilling to comply with protocol requirements.
• • Expected life expectancy \< 6 months.
• • Previous MTT or microbiome-based products at any time excluding this study.
• • History of severe anaphylactic or anaphylactoid food allergy.
• • Solid organ transplant recipients 90 days post-transplant or on active treatment for rejection.
• • A condition that would jeopardize the safety or rights of the subject, would make it unlikely for the subject to complete the study, or would confound the results of the study.
• • History of or existing skin diseases affecting the scalp such as psoriasis or seborrheic dermatitis and patients with evidence of infection or skin cancer in the treated areas.
• • Patients in whom the diagnosis of alopecia areata is questionable.
• • Patients in whom regrowth is present/evident at baseline in the areas to be treated.
• • Patients with active medical conditions or malignancies (except adequately treated basal or squamous cell carcinoma of the skin) which in the opinion of the investigator would increase the risks associated with study participation, including patients with a history of recurrent infections.
• • Patients unwilling or unable to discontinue treatments known to affect hair regrowth in alopecia areata.
• • Patients who have been treated with intralesional steroids, systemic steroids, anthralin, squaric acid, DPCP (diphenylcycloprophenone), protopic, minoxidil, JAK inhibitors or other medication which in the opinion of the investigator may affect hair regrowth, within one month of the baseline visit..
• • Patients determined by the investigator to have extreme diets..
• • Pregnant and breastfeeding females..