Fecal Transplant for Alopecia Areata

NCT04833179 | Unknown

• 1 other identifier: 001320
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alopecia Areata

Keywords

Alopecia Areata; Fecal transplant; Microbiome

Outcome Measures

Primary Outcomes (3)

• 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. 1. left side view = ALOPECIA% x 18% 2. right side view = ALOPECIA% x 18% 3. top of scalp = ALOPECIA% x 40% 4. 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.

  1. \<25% regrowth. 2. 25%\<x\<50% regrowth. 3. 50%\<x\<70%regrowth. 4. \>75% regrowth. 5. 100% regrowth.

  up to1 year after fecal transplantation

Study Arms (2)

fecal transplant

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

fecal transplant 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.

fecal transplant

placebo OTHER

placebo

placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

MeSH Terms

Conditions

Alopecia Areata

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Liat Samueluv, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Efrat Bar-Ilan, MD

CONTACT

+972-54-8186226; efratbarilan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Liat Samuelov MD. Vice Chair, Division of Dermatology, Tel Aviv Sourasky Medical Center

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: April 6, 2021
• Study Start: May 1, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2025
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share