Fecal Transplant for Alopecia Areata

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 Overview

• Status: Not yet recruiting
• Conditions: Alopecia Areata
• Intervention / Treatment: Biological: fecal transplant; Other: placebo

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 Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Efrat Bar-Ilan, MD; Phone Number: +972-54-8186226; Email: efratbarilan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

1. Patients who were treated with systemic corticosteroids / corticosteroids injection one year prior the study.
2. Patients who were treated with topical corticosteroids two weeks prior the study.
3. Patients who were treated with immunosuppressing medications or biological treatments one year prior the study.
4. Patients who were treated with systemic antibiotics of any kind 3 months prior the study.
5. Patient who were treated with topical antibiotics one months prior the study.
6. Patients who were treated with probiotics one months prior the study.
7. Patients with alopecia universalis (total loss of all body, scalp and facial hair).
8. Patients with bowel disease or an active infection including clostridium difficile.
9. Pregnant and breastfeeding women.
10. Childrenbelow the age of 18.
11. Malignant disease in the past 5 years.
12. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fecal transplant; 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.	Biological: fecal transplant; 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.
Placebo Comparator: placebo; 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.	Other: placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	up to1 year after fecal transplantation
patient assessment.	<25% regrowth.; 25%<x<50% regrowth.; 50%<x<70%regrowth.; >75% regrowth.; 100% regrowth.	up to1 year after fecal transplantation

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Liat Samueluv, MD, Vice chair, Department of Dermatology Tel Aviv Sourasky Medical center, Israel

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: April 3, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 3, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Microbiome; Alopecia Areata; Fecal transplant
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: 001320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No