A Phase 2 interventional study of Fecal material transfer therapy and 4mm Punch Biopsy of Scalp in Alopecia Areata, Alopecia Totalis and Alopecia Universalis, sponsored by Lindsey Bordone. Withdrawn. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-03-21.
Sponsored by Lindsey Bordone · Phase 2, Interventional, and Treatment
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.
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.
609 studies on the registry are indexed under Alopecia; 129 are open to participants now.
Browse Alopecia studies →This is the only study on the registry with Lindsey Bordone as lead sponsor.
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Exclusion Criteria:
Participants will take a standardized regimen of antibiotics for three days prior to fecal transplant.
Drug: Fecal material transfer therapy · Procedure: 4mm Punch Biopsy of Scalp · Diagnostic Test: Blood draw · Procedure: Skin Microbiome sampling · Procedure: Hair Microbiome Sampling · Drug: Pre-FMT Antibiotic Cocktail · Drug: Bowel Prep
Participants will not take antibiotics before the transplant.
Drug: Fecal material transfer therapy · Procedure: 4mm Punch Biopsy of Scalp · Diagnostic Test: Blood draw · Procedure: Skin Microbiome sampling · Procedure: Hair Microbiome Sampling · Drug: Bowel Prep
Fecal microbiota transplants will be performed as follows: FMP Retention Enema: (FMP 250 mL) Dosage Form: Screened human donor stool, suspended in diluent of 12.5% glycerol and sterile normal saline buffer (0.9% NaCl) standardized to a 5X concentration (1g stool : 5mL diluent ratio), homogenized, filtered to 330 microns and aliquoted to sterile 250mL vessels. Route of Administration: Fecal transplant will be performed under medical supervision. Lubricated enema tube will be inserted into rectum and contents expelled into the distal colon with the subject requested to retain material for a target dwell time of 3 to 24 hours with a mean target of 10 hours. Participants will lie in the left lateral decubitus position but if mobility permits will rotate to supine and right lateral decubitus position. One half of study subjects will receive a 3 day course of antibiotics prior to fecal transplant, while the other half will not.
Also known as: FMT
For the skin biopsy, the doctor will select an appropriate area on the scalp (or skin) as the biopsy site. The area will then be numbed (anesthetized). The study doctor or his/hers designee will then use a cylindrical instrument with a sharp edge (similar to a small cookie-cutter) to remove a 4mm cylinder of skin (smaller than the size of a pencil eraser). After the skin is removed, the biopsy site will be closed with absorbable stitches when appropriate. Approximately 2 to 4 stitches may be placed at the wound site to improve healing. Multiple skin punch biopsies may be taken throughout the entire length of the study
Also known as: Punch Biopsy of Scalp
Blood will be collected by a standard venipuncture procedure. 60-80cc of blood will be drawn from a patient per blood draw occurrence. Blood samples will be transferred to the research facility. Samples will be used to either stained with cell surface antibodies for fluorescence acquisition cell sorting (FACS) analysis (FACS experiments will allow for assessment of the subset and activation status of immune cells involved in AA or other cutaneous disorder pathology) or to extract DNA for the purposes of exome or genomic sequencing or genotyping of disease associated genes
Skin microbiome will be collected using skin swabs at the time of recruitment according to established protocols outlined by the Human Microbiome Project. Sterile (germ-free) techniques will be used for collection of all specimens, with careful avoidance of contamination of collection area by gloved hands. The sites that will be sampled are (in sequence): Lesional AA skin, non-lesional scalp skin, retro-auricular crease, ante-cubital fossa, and anterior nares. Skin surface specimens will be collected with a Catch-All Sample Collection Swab swab that looks similar to a q-tip and is, moistened with sterile solution. Skin will be swabbed approximately 50 times along the scalp, behind your ear and on your arm, and twisted 2 times around the front of the nose.
Hair follicle microbiome (bacteria that live in the hair follicle) will be collected as follows: several hairs will be plucked from the scalp at a time using tweezers, once plucked the bulbs of the hairs will be cut using sterile surgical scissors and processed. Approximately 10-15 hairs will be plucked for processing. The number of hairs plucked may be increased depending on the number of hairs containing bulbs. Up to 50 hairs may be plucked, as long as the subject is able to tolerate it. Only several hairs will be plucked at a time in order to minimize pain and discomfort of the procedure.
For three days prior to the transplant, one half (20) of the subjects enrolled will be treated with antibiotics to reduce the burden of the existing microbiome. The antibiotic regimen will consist of: oral vancomycin 250 mg qid, ciprofloxacin 500 mg bid, and metronidazole 500 mg tid. For subjects who have antibiotic allergies, appropriate antibiotic substitutions will be made. Subjects will stop the antibiotics 48 hours before the fecal transplant.
The night before the transplant, all enrolled subjects will take 20 mg of bisacodyl and a large volume bowel preparation (GoLyteley 4000cc). Fecal transplant will be performed under medical supervision. After the transplant, subjects will take 4 mg of loperamide to increase transplant retention.
Number of responders in patients treated with FMT
Responders are defined as subjects achieving 50% or greater (% change, NOT absolute change) hair re-growth from baseline as assessed by SALT (Severity of Alopecia Tool) score where 0 indicates no hair and 100 is a full head of hair (i.e. 50% regrowth at week 24). A higher SALT score/ higher percent change indicate a better outcome.
Time frame: 24 weeks post-treatment
Proportion of participants with an adverse event (AE) through day 30 (±3 days) after FMT
Time frame: 30 days post-treatment
Proportion of participants with a serious adverse event (SAE) through day 30 (±3 days) after FMT
Time frame: 30 days post-treatment
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
Time frame: 30 days post-treatment
Time of relapse in responders
The timing of relapse in responders will be followed for 6 months post therapy.
Time frame: 24 weeks post-treatment
Proportion of participants with an AE through week 4 (±5 days) after FMT
Time frame: 4 weeks post-treatment
Proportion of participants with an SAE through week 4 (±5 days) after FMT
Time frame: 4 weeks post-treatment
Proportion of participants with a SAE at month 6 (±14 days) after randomization
Time frame: 6 months post-randomization
Proportion of participants with a SAE at month 12 (±14 days) after randomization
Time frame: 12 months post-randomization
Percent hair regrowth from baseline
This will be determined by SALT measurements.
Time frame: 24 weeks post-treatment
No study locations are listed for this record.
Plan to share: No
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