Back to resultsFecal Transplant for Alopecia Areata
Primary Purpose
Alopecia Areata
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fecal transplant
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia Areata, Fecal transplant, Microbiome
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
fecal transplant
placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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)
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)
patient assessment.
<25% regrowth.
25%<x<50% regrowth.
50%<x<70%regrowth.
>75% regrowth.
100% regrowth.
Secondary Outcome Measures
Full Information
NCT ID
NCT04833179
First Posted
March 1, 2021
Last Updated
April 3, 2021
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04833179
Brief Title
Fecal Transplant for Alopecia Areata
Official Title
Fecal Transplant for Alopecia Areata
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2021 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Alopecia Areata, Fecal transplant, Microbiome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fecal transplant
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
fecal transplant
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Severity alopecia tool score - SALT score I
Description
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)
Time Frame
up to1 year after fecal transplantation
Title
Alopecia Areata Progression Index, AAPI
Description
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)
Time Frame
up to1 year after fecal transplantation
Title
patient assessment.
Description
<25% regrowth.
25%<x<50% regrowth.
50%<x<70%regrowth.
>75% regrowth.
100% regrowth.
Time Frame
up to1 year after fecal transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Efrat Bar-Ilan, MD
Phone
+972-54-8186226
Email
efratbarilan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liat Samueluv, MD
Organizational Affiliation
Vice chair, Department of Dermatology Tel Aviv Sourasky Medical center, Israel
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fecal Transplant for Alopecia Areata
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