Fecal Transplant for Alopecia Areata

Tel Aviv Sourasky Medical Center

Status: Not yet enrolling

Conditions: Alopecia Areata

Treatments: Other: placebo; Biological: fecal transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT04833179

001320

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups, including a placebo group

fecal transplant

Experimental group

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.

Treatment:

Biological: fecal transplant

placebo

Placebo Comparator group

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.

Treatment:

Other: placebo