Clinical trial NCT04238091: Clinical Trial to Evaluate the Efficacy of Fecal Microbiota Transplantation in Patients With Alopecia Areata
Official title: Open Label Clinical Trial to Evaluate the Efficacy of Fecal Microbiota Transplantation in Patients With Alopecia Areata
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Alopecia Areata
Alopecia Totalis
Alopecia Universalis
Keywords: Hair Loss
Alopecia
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Alopecia areata (AA) is an autoimmune condition resulting in chronic and relapsing hair loss. AA patchy is associated with well-circumscribed patches of hair loss, commonly on the scalp or face, while alopecia totalis (AT) and alopecia universalis (AU) are two severe types of AA characterized by 95% or more hair loss on the scalp (AT) or body (AU). Although the exact underlying mechanisms that cause AA are unknown, T lymphocyte cells are implicated, as they release pro-inflammatory cytokines and chemokines around the hair follicles, triggering a cascade and ultimately resulting in hair loss.

Fecal microbiota transfer (FMT) involves the transfer of stool (feces) from a healthy donor to an AA recipient. Research suggests that changing the type of bacteria in an individual's intestine may carry the potential to alter (increase or decrease) the recipient's potential for certain conditions, even autoimmune conditions.

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 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.

Primary outcomes:
measure: Number of responders in patients treated with FMT
timeFrame: 24 weeks post-treatment
measure: Proportion of participants with an adverse event (AE) through day 30 (±3 days) after FMT
timeFrame: 30 days post-treatment
measure: Proportion of participants with a serious adverse event (SAE) through day 30 (±3 days) after FMT
timeFrame: 30 days post-treatment
measure: Proportion of participants with newly acquired transmissible infectious diseases which are considered adverse events of special interest (AESI) through day 30 (±3 days) after FMT
timeFrame: 30 days post-treatment
Secondary outcomes:
measure: Time of relapse in responders
timeFrame: 24 weeks post-treatment
measure: Proportion of participants with an AE through week 4 (±5 days) after FMT
timeFrame: 4 weeks post-treatment
measure: Proportion of participants with an SAE through week 4 (±5 days) after FMT
timeFrame: 4 weeks post-treatment
measure: Proportion of participants with a SAE at month 6 (±14 days) after randomization
timeFrame: 6 months post-randomization
measure: Proportion of participants with a SAE at month 12 (±14 days) after randomization
timeFrame: 12 months post-randomization
measure: Percent hair regrowth from baseline
timeFrame: 24 weeks post-treatment
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: Lindsey Bordone, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xie WR, Yang XY, Xia HH, Wu LH, He XX. Hair regrowth following fecal microbiota transplantation in an elderly patient with alopecia areata: A case report and review of the literature. World J Clin Cases. 2019 Oct 6;7(19):3074-3081. doi: 10.12998/wjcc.v7.i19.3074.
citation: Rebello D, Wang E, Yen E, Lio PA, Kelly CR. Hair Growth in Two Alopecia Patients after Fecal Microbiota Transplant. ACG Case Rep J. 2017 Sep 13;4:e107. doi: 10.14309/crj.2017.107. eCollection 2017.