Alopecia AreataNCT04833179
Fecal Transplant for Alopecia Areata
A study testing fecal transplant in people with Alopecia Areata, run by Tel-Aviv Sourasky Medical Center.
Trial summary
the investigators intend to analyze the microbiome in the diseased areas, healthy skin and fecal samples. In addition, the investigators plan to evaluate how the fecal transplant can influence the severity of the disease and hair growth, all in hope that fecal transplant can help to treat or even cure AA. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- fecal transplant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Apr 2025
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AA patients with:
- Acute disease that appeared in the last 3 months.
- Recurrence of AA in the last 3 months, in a patient who had remission for at least one year.
- At least one patch of hair loss on the scalp and / or the beard, or with a widespread disease such as total loss of the hair over the entire scalp (alopecia totalis).
- In case of a single alopetic patch, the patch must be equal or bigger than 2 cm in diameter.
- All patients will be diagnosed by two separate dermatologist, or one dermatologist with the support of classical finding on skin biopsy.
Who cannot join
- Patients who were treated with systemic corticosteroids / corticosteroids injection one year prior the study.
- Patients who were treated with topical corticosteroids two weeks prior the study.
- Patients who were treated with immunosuppressing medications or biological treatments one year prior the study.
- Patients who were treated with systemic antibiotics of any kind 3 months prior the study.
- Patient who were treated with topical antibiotics one months prior the study.
- Patients who were treated with probiotics one months prior the study.
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- Patients with alopecia universalis (total loss of all body, scalp and facial hair).
- Patients with bowel disease or an active infection including clostridium difficile.
- Pregnant and breastfeeding women.
- Childrenbelow the age of 18.
- Malignant disease in the past 5 years.
- Patient with any infectious disease that require antibiotics during the study period.
- In any case a patient would like to withdraw from the study, for any reason, all samples will be destroyed immediately, and the patient will stop his participant in the study.
Trial locations and contacts
No sites are listed yet.
About this study
the investigators intend to analyze the microbiome in the diseased areas, healthy skin and fecal samples. In addition, the investigators plan to evaluate how the fecal transplant can influence the severity of the disease and hair growth, all in hope that fecal transplant can help to treat or even cure AA. This may help dermatologists in the future and expand the treatment options for AA.
Read the detailed description
Alopecia areata (AA) is a common autoimmune disease that triggers non scarring hair loss in different severities. Usually the hair loss will be contained to the scalp and / or beard, but in some cases, there will be total hair loss from the entire scalp (alopecia totalis), or complete loss of all body, facial and scalp hair (alopecia universalis).
AA is an autoimmune disease that produces an inflammation surrounding the hair follicles, this leads to temporary hair loss. In cases the disease become chronic, the immune system attack may lead to a permanent hair loss. This common hair disease has a significant impact on the patient's quality of life, it can cause impairment on the patient's confidence, self-esteem, lead to depression and more.
Lately two patients with AA and clostridium difficile infection were treated with fecal transplantation for their infection (Rebello et al. 2017). After the transplant a significant improvement was notice in hair growth. These 2 cases raised the option that a fecal transplant may have an additional effect on the autoimmune reaction against the hair follicle in AA.
the investigators intend to analyze the microbiome in the diseased areas, healthy skin and fecal samples. In addition, the investigators plan to evaluate how the fecal transplant can influence the severity of the disease and hair growth, all in hope that fecal transplant can help to treat or even cure AA. This may help dermatologists in the future and expand the treatment options for AA.
- Conditions
- Alopecia Areata
- Being tested
- fecal transplant, placebo
- Keywords
- Alopecia Areata, Fecal transplant, Microbiome
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal transplantBiological
Healthy donors will be selected by the fecal transplant unit, in Tel-Aviv medical center. All donors will undergo a screening process that will include a detailed medical history, blood work and fecal tests. Only after passing the screening, the donor will be added to the groups of donors that will participant in this study.
The treatment will be givenin the form of fecal capsule. Each capsule will contain a double capsule with 2 layers to ensure that the fecal material will be contained. The treatments will include 30 capsules for the first treatment, that will be taken in two consecutive days, each day 15 capsules. The second, third and fourth treatments will all include 15 fecal capsules. There will be 2 weeks intervals between each treatment.
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| fecal transplant | Experimental | Healthy donors will be selected by the fecal transplant unit, in Tel-Aviv medical center. The treatment will be given in the form of fecal capsule. Each capsule will contain a double capsule with 2 layers to ensure that the fecal material will be contained. The treatments will include 30 capsules for the first treatment, that will be taken in two consecutive days, each day 15 capsules. The second, third and fourth treatments will all include 15 fecal capsules. There will be 2 weeks intervals between each treatment. Receives: Biological: fecal transplant |
| placebo | Placebo comparator | Placebo capsule that can not be differentiate from the focal transplant capsule will be given in the same interval as the fecal transplant procedure written above. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity alopecia tool score - SALT score I
The SALT score I (Olsen, 2004) is a global severity score that captures percentage hair loss.
The scalp area is divided into 4 quadrants - Left (L) Right (R) Back (B) Top (T). Photographs taken of the four views of the scalp. The percentage of hair loss in any one of the four views (areas) of the scalp = the percentage hair loss X percent surface area of the scalp in that area.
- left side view = ALOPECIA% x 18%
- right side view = ALOPECIA% x 18%
- top of scalp = ALOPECIA% x 40%
- back of scalp = ALOPECIA% x 24% The SUM of all equals the score. (possible score range: 0-100)
Measured: up to1 year after fecal transplantation
Alopecia Areata Progression Index, AAPI
formula for the total AAPI score (possible score range: 0-600). The scalp area is divided into 4 quadrants - Left (L) Right (R) Back (B) Top (T) using the Olsen/Canfield tool. The percent alopecic area (%AA) and score of hair loss activity (SL) is determined in each quadrant.
The %AA is defined as the percentage of alopecic area in each compartment. SL is calculated as the sum of the results of hair pull tests (2 = positive, excessive, i.e. >20% of grasped hairs; 1 = positive, not excessive, 10-20%; 0 = negative, <10%) and the magnification findings associated with hair loss activity such as exclamation mark hairs, broken hairs and black dots (4 = ≥50%, 2 = <50%, 0 = 0%) in each quadrant.
The total AAPI score is calculated by the following formula:
[%AA(L) × SL(L) × 0.18] + [%AA(R) × SL(R) × 0.18] + [%AA(T) × SL(T) × 0.4] + [%AA(B) × SL(B) × 0.24].
(possible score range: 0-600)
Measured: up to1 year after fecal transplantation
patient assessment.
- <25% regrowth.
- 25%<x<50% regrowth.
- 50%<x<70%regrowth.
- >75% regrowth.
- 100% regrowth.
Measured: up to1 year after fecal transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study startMay 2021 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 110 patients with alopecia areata. Prior the beginning of the study all subjects will undergo: Complete physical examination Clinical image of involved locations will be taken Estimating the severity of the disease Microbiome samples Blood sample The patients with AA will undergo randomization into two groups. Group 1 - the subjects will receive a complete fecal transplant course. Group 2 - the subjects will receive placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center
- Investigators
- Liat Samueluv, MD, Principal investigator, Vice chair, Department of Dermatology Tel Aviv Sourasky Medical center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833179
- Sponsor's protocol ID
- 001320
- Status last verified
- Apr 2021
- First submitted
- 1 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Transplant for Alopecia Areata
- ClinicalTrials.gov ID
- NCT04833179
- Acronym / sponsor ID
- 001320
- Conditions
- Alopecia Areata
- Keywords
- Alopecia Areata, Fecal transplant, Microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- May 2021 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 6 Apr 2021 (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 investigators intend to analyze the microbiome in the diseased areas, healthy skin and fecal samples. In addition, the investigators plan to evaluate how the fecal transplant can influence the severity of the disease and hair growth, all in hope that fecal transplant can help to treat or even cure AA. This may help dermatologists in the future and expand the treatment options for AA.
Detailed description
Alopecia areata (AA) is a common autoimmune disease that triggers non scarring hair loss in different severities. Usually the hair loss will be contained to the scalp and / or beard, but in some cases, there will be total hair loss from the entire scalp (alopecia totalis), or complete loss of all body, facial and scalp hair (alopecia universalis).
AA is an autoimmune disease that produces an inflammation surrounding the hair follicles, this leads to temporary hair loss. In cases the disease become chronic, the immune system attack may lead to a permanent hair loss. This common hair disease has a significant impact on the patient's quality of life, it can cause impairment on the patient's confidence, self-esteem, lead to depression and more.
Lately two patients with AA and clostridium difficile infection were treated with fecal transplantation for their infection (Rebello et al. 2017). After the transplant a significant improvement was notice in hair growth. These 2 cases raised the option that a fecal transplant may have an additional effect on the autoimmune reaction against the hair follicle in AA.
the investigators intend to analyze the microbiome in the diseased areas, healthy skin and fecal samples. In addition, the investigators plan to evaluate how the fecal transplant can influence the severity of the disease and hair growth, all in hope that fecal transplant can help to treat or even cure AA. This may help dermatologists in the future and expand the treatment options for AA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 110 patients with alopecia areata. Prior the beginning of the study all subjects will undergo: Complete physical examination Clinical image of involved locations will be taken Estimating the severity of the disease Microbiome samples Blood sample The patients with AA will undergo randomization into two groups. Group 1 - the subjects will receive a complete fecal transplant course. Group 2 - the subjects will receive placebo.
| Arm | Type | Receives |
|---|---|---|
| fecal transplant | Experimental | Biological: fecal transplantHealthy donors will be selected by the fecal transplant unit, in Tel-Aviv medical center. The treatment will be given in the form of fecal capsule. Each capsule will contain a double capsule with 2 layers to ensure that the fecal material will be contained. The treatments will include 30 capsules for the first treatment, that will be taken in two consecutive days, each day 15 capsules. The second, third and fourth treatments will all include 15 fecal capsules. There will be 2 weeks intervals between each treatment. |
| placebo | Placebo comparator | Other: placeboPlacebo capsule that can not be differentiate from the focal transplant capsule will be given in the same interval as the fecal transplant procedure written above. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Acute disease that appeared in the last 3 months.
- Recurrence of AA in the last 3 months, in a patient who had remission for at least one year.
- At least one patch of hair loss on the scalp and / or the beard, or with a widespread disease such as total loss of the hair over the entire scalp (alopecia totalis).
- In case of a single alopetic patch, the patch must be equal or bigger than 2 cm in diameter.
- All patients will be diagnosed by two separate dermatologist, or one dermatologist with the support of classical finding on skin biopsy.
Key exclusion criteria (13 listed)
- Patients who were treated with systemic corticosteroids / corticosteroids injection one year prior the study.
- Patients who were treated with topical corticosteroids two weeks prior the study.
- Patients who were treated with immunosuppressing medications or biological treatments one year prior the study.
- Patients who were treated with systemic antibiotics of any kind 3 months prior the study.
- Patient who were treated with topical antibiotics one months prior the study.
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 transplantHealthy donors will be selected by the fecal transplant unit, in Tel-Aviv medical center. All donors will undergo a screening process that will include a detailed medical history, blood work and fecal tests. Only after passing the screening, the donor will be added to the groups of donors that will participant in this study. The treatment will be givenin the form of fecal capsule. Each capsule will contain a double capsule with 2 layers to ensure that the fecal material will be contained. The treatments will include 30 capsules for the first treatment, that will be taken in two consecutive days, each day 15 capsules. The second, third and fourth treatments will all include 15 fecal capsules. There will be 2 weeks intervals between each treatment. | Biological | fecal transplant |
| placeboplacebo | Other | placebo |
Primary outcome
Severity alopecia tool score - SALT score I
Time frame: up to1 year after fecal transplantation
The SALT score I (Olsen, 2004) is a global severity score that captures percentage hair loss. The scalp area is divided into 4 quadrants - Left (L) Right (R) Back (B) Top (T). Photographs taken of the four views of the scalp. The percentage of hair loss in any one of the four views (areas) of the scalp = the percentage hair loss X percent surface area of the scalp in that area. 1. left side view = ALOPECIA% x 18% 2. right side view = ALOPECIA% x 18% 3. top of scalp = ALOPECIA% x 40% 4. back of scalp = ALOPECIA% x 24% The SUM of all equals the score. (possible score range: 0-100)
Alopecia Areata Progression Index, AAPI
Time frame: up to1 year after fecal transplantation
formula for the total AAPI score (possible score range: 0-600). The scalp area is divided into 4 quadrants - Left (L) Right (R) Back (B) Top (T) using the Olsen/Canfield tool. The percent alopecic area (%AA) and score of hair loss activity (SL) is determined in each quadrant. The %AA is defined as the percentage of alopecic area in each compartment. SL is calculated as the sum of the results of hair pull tests (2 = positive, excessive, i.e. >20% of grasped hairs; 1 = positive, not excessive, 10-20%; 0 = negative, <10%) and the magnification findings associated with hair loss activity such as exclamation mark hairs, broken hairs and black dots (4 = ≥50%, 2 = <50%, 0 = 0%) in each quadrant. The total AAPI score is calculated by the following formula: [%AA(L) × SL(L) × 0.18] + [%AA(R) × SL(R) × 0.18] + [%AA(T) × SL(T) × 0.4] + [%AA(B) × SL(B) × 0.24]. (possible score range: 0-600)
patient assessment.
Time frame: up to1 year after fecal transplantation
1. <25% regrowth. 2. 25%<x<50% regrowth. 3. 50%<x<70%regrowth. 4. >75% regrowth. 5. 100% regrowth.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Liat Samueluv, MD principal investigator
Vice chair, Department of Dermatology Tel Aviv Sourasky Medical center, Israel
Questions about this trial
What is this clinical trial studying?
A study testing fecal transplant in people with Alopecia Areata, run by Tel-Aviv Sourasky Medical Center.
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 13 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: status not confirmed, as of the sponsor's last update on 6 Apr 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Efrat Bar-Ilan, MD (+972-54-8186226, efratbarilan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity alopecia tool score - SALT score I (time frame: up to1 year after fecal transplantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2021.