Clinical trial NCT04833179: Fecal Transplant for Alopecia Areata
Official title: Fecal Transplant for Alopecia Areata
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alopecia Areata
Keywords: Alopecia Areata
Fecal transplant
Microbiome
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2021-04-06
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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:

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.

Primary outcomes:
measure: Severity alopecia tool score - SALT score I
timeFrame: up to1 year after fecal transplantation
measure: Alopecia Areata Progression Index, AAPI
timeFrame: up to1 year after fecal transplantation
measure: patient assessment.
timeFrame: up to1 year after fecal transplantation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vice chair, Department of Dermatology Tel Aviv Sourasky Medical center, Israel
name: Liat Samueluv, MD
role: PRINCIPAL_INVESTIGATOR
References: