Clinical Trial to Evaluate the Efficacy of Fecal Microbiota Transplantation in Patients With Alopecia Areata

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine fecal transfer as a potential treatment for Alopecia Areata (AA). This trial will attempt to discover if fecal transfer can treat immune-related hair loss.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular

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 greater than 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 FMT on the day of FMT, and

• 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 FMT. Acceptable forms of contraception include Oral/intramuscular (IM) contraceptives, intrauterine device (IUD), surgical sterilization.

Exclusion Criteria:

• Inability (e.g. dysphagia) to or unwilling to swallow capsules

• Active gastrointestinal infection at time of enrollment

• Patient received 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 or anticipates antibiotic use in the upcoming 4 weeks

• Known or suspected toxic megacolon and/or known small bowel ileus

• Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment. This does not include appendectomy or cholecystectomy

• History of total colectomy or bariatric surgery

• 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 FMT or microbiome-based products at any time excluding this study

• Patients with a history of severe anaphylactic or anaphylactoid food allergy

• Solid organ transplant recipients 90 days post-transplant or on active treatment for rejection

• If at risk for CMV/EBV associated disease (at investigator's discretion, e.g. immunocompromised), negative immunoglobulin G (igG) testing for cytomegalovirus (CMV) or Epstein Barr Virus (EBV).

• 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

• Patients with a 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 known to be HIV or hepatitis B or C positive or otherwise immunocompromised

• 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, diphenylcyclopropenone (DPCP), protopic, minoxidil, Janus kinase (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.

• Patients (children) under the age of 18.

• Pregnant and breastfeeding females.