Alopecia AreataPhase 2NCT04238091
Clinical Trial to Evaluate the Efficacy of Fecal Microbiota Transplantation in Patients With Alopecia Areata
A Phase 2 study testing Fecal material transfer therapy, 4mm Punch Biopsy of Scalp and Blood draw in people with Alopecia Areata and Alopecia Totalis, run by Lindsey Bordone.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis
- What is being tested?
- Fecal material transfer therapy, 4mm Punch Biopsy of Scalp and Blood draw
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 19 Dec 2019to 2 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 25Show fewer
- 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.
About this study
Official title: Open Label Clinical Trial to Evaluate the Efficacy of Fecal Microbiota Transplantation in Patients With Alopecia Areata
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.
Read the 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.
- Conditions
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis
- Being tested
- Fecal material transfer therapy, 4mm Punch Biopsy of Scalp, Blood draw, Skin Microbiome sampling, Hair Microbiome Sampling
- Keywords
- Hair Loss, Alopecia
- Medical subject headings
- Alopecia Areata, Alopecia universalis, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal material transfer therapyDrug
Also called FMT
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.
4mm Punch Biopsy of ScalpProcedure or surgery
Also called Punch Biopsy of Scalp
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
Blood drawDiagnostic test
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 samplingProcedure or surgery
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 Microbiome SamplingProcedure or surgery
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.
Pre-FMT Antibiotic CocktailDrug
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.
Bowel PrepDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics prior to FMT | Active comparator | Participants will take a standardized regimen of antibiotics for three days prior to fecal transplant. Receives: 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 |
| No Antibiotics prior to FMT | Active comparator | Participants will not take antibiotics before the transplant. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks post-treatment
Proportion of participants with an adverse event (AE) through day 30 (±3 days) after FMT
Measured: 30 days post-treatment
Proportion of participants with a serious adverse event (SAE) through day 30 (±3 days) after FMT
Measured: 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
Measured: 30 days post-treatment
Secondary outcomes (6)
Time of relapse in responders
The timing of relapse in responders will be followed for 6 months post therapy.
Measured: 24 weeks post-treatment
Proportion of participants with an AE through week 4 (±5 days) after FMT
Measured: 4 weeks post-treatment
Proportion of participants with an SAE through week 4 (±5 days) after FMT
Measured: 4 weeks post-treatment
Proportion of participants with a SAE at month 6 (±14 days) after randomization
Measured: 6 months post-randomization
Proportion of participants with a SAE at month 12 (±14 days) after randomization
Measured: 12 months post-randomization
Percent hair regrowth from baseline
This will be determined by SALT measurements.
Measured: 24 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start19 Dec 2019
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
Why it stopped: Investigator is no longer interested in moving forward with this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindsey Bordone
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lindsey Bordone, Columbia University
- Investigators
- Lindsey Bordone, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238091
- Sponsor's protocol ID
- AAAS4183
- Status last verified
- Mar 2022
- First submitted
- 14 Jan 2020
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31624757Rebello 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.
PubMed 28932754
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Clinical Trial to Evaluate the Efficacy of Fecal Microbiota Transplantation in Patients With Alopecia Areata
- ClinicalTrials.gov ID
- NCT04238091
- Acronym / sponsor ID
- AAAS4183
- Conditions
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis
- Keywords
- Hair Loss, Alopecia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator is no longer interested in moving forward with this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lindsey BordoneUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics prior to FMT | Active comparator | 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 PrepParticipants will take a standardized regimen of antibiotics for three days prior to fecal transplant. |
| No Antibiotics prior to FMT | Active comparator | 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 PrepParticipants will not take antibiotics before the transplant. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal material transfer therapyAlso: FMTFecal 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. | Drug | Antibiotics prior to FMT, No Antibiotics prior to FMT |
| 4mm Punch Biopsy of ScalpAlso: Punch Biopsy of ScalpFor 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 | Procedure or surgery | Antibiotics prior to FMT, No Antibiotics prior to FMT |
| Blood drawBlood 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 | Diagnostic test | Antibiotics prior to FMT, No Antibiotics prior to FMT |
| Skin Microbiome samplingSkin 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. | Procedure or surgery | Antibiotics prior to FMT, No Antibiotics prior to FMT |
| Hair Microbiome SamplingHair 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. | Procedure or surgery | Antibiotics prior to FMT, No Antibiotics prior to FMT |
| Pre-FMT Antibiotic CocktailFor 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. | Drug | Antibiotics prior to FMT |
| Bowel PrepThe 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. | Drug | Antibiotics prior to FMT, No Antibiotics prior to FMT |
Primary outcome
Number of responders in patients treated with FMT
Time frame: 24 weeks post-treatment
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.
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
6 secondary outcomes
Time of relapse in responders
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
Time frame: 24 weeks post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Background: PubMed 31624757Xie 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.
- Background: PubMed 28932754Rebello 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.
- Individual participant dataSharing planned: No
Related trials for Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsey Bordone, MD principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fecal material transfer therapy, 4mm Punch Biopsy of Scalp and Blood draw in people with Alopecia Areata and Alopecia Totalis, run by Lindsey Bordone.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of responders in patients treated with FMT (time frame: 24 weeks post-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04238091, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.