Fecal Transplant for Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

Fecal Transplant for Alopecia Areata

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04833179
• Other study ID #: 001320
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2021
• Est. completion date: April 2025

Study information

• Verified date: April 2021
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Efrat Bar-Ilan, MD
• Phone: +972-54-8186226
• Email: efratbarilan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This may help dermatologists in the future and expand the treatment options for AA.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: April 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

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.

Other:
• placebo
placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	patient assessment.	<25% regrowth.; 25%50%>75% regrowth.; 100% regrowth.	up to1 year after fecal transplantation