Fecal Transplant for Alopecia Areata

NCT ID: NCT04833179

Last Updated: 2021-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-31
• Study Completion Date: 2025-04-30

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.

Conditions

Alopecia Areata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

fecal transplant

Intervention Type: BIOLOGICAL

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

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

placebo

Interventions

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.

Intervention Type: BIOLOGICAL

placebo

placebo

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Eli Sprecher, MD

Liat Samuelov MD. Vice Chair, Division of Dermatology, Tel Aviv Sourasky Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liat Samueluv, MD

Role: PRINCIPAL_INVESTIGATOR

Vice chair, Department of Dermatology Tel Aviv Sourasky Medical center, Israel

Central Contacts

Efrat Bar-Ilan, MD

Role: CONTACT

efratbarilan@gmail.com

+972-54-8186226

Other Identifiers

001320

Identifier Type: -

Identifier Source: org_study_id