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New treatment option for Alopecia Areata
Official title Evaluation of Microbiota Transplant Therapy in Patients With Alopecia Areata
ClinicalTrials.gov ID: NCT06747611
What this study is testing
What is Vancomycin, Neomycin and MTT capsules?
Vancomycin, Neomycin and MTT capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for alopecia areata.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Alopecia Areata (AA) is among the most highly prevalent human autoimmune diseases, leading to disfiguring hair loss due to the collapse of immune privilege of the hair follicle and subsequent autoimmune attack. AA affects about 5.3 million people in the United States alone, including males and females across all ethnic groups, with a lifetime risk of 2.1%.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility 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...
- 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.
- 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...
- 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...
- Patients determined by the investigator to have extreme diets..
- Pregnant and breastfeeding females..
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.