A clinical trial of fecal transplantation for atopic dermatitis (“FMT”) has started in Israel.

We are pleased to present a report that a clinical trial of fecal transplantation for atopic dermatitis (hereafter referred to as FMT) has begun in Israel.
Detailed clinical trial and patient information is as follows
〇 Based on a double-blind study.

original：Efficacy of Fecal Microbial Transplantation Treatment in Adults With Atopic Dermatitis – Full Text View – ClinicalTrials.gov

【About the patient】

Patient age: 18 years and older
Patient gender: male/female
Patientseverity: moderate to severe, severity is assessed by the internationally used SCORAD score (the Scoring Atopic Dermatitis Score) and the Investigator Global Assessment scale for Atopic Dermatitis (IGA).
As a supplement, the SCORAD score evaluates the area of the atopic dermatitis rash, the intensity of the rash, and subjective symptoms, and is scored on a 103-point scale. In this clinical trial, patients with moderate to severe disease who score 25 points or higher will be targeted.
The IGA, also known as the “skin lesion score” in Japanese, is a five-point scale from 0 to 4, with 4 being the most severe. It evaluates how severe the lesion is on a scale of 0 to 4.

【About the method of the clinical trial】

〇 Methods:
Patients will be divided into two groups. Both groups 1 and 2 will receive FMT or placebo implants four times every two weeks. Patients will not begin any new treatments, but will be allowed to continue any local or systemic treatment of moisturizers or glycocorticoids that they have been receiving.
In addition, at the beginning of this trial, just prior to transplantation, and one to six months after transplantation, the severity of the patient’s disease will be measured using three indicators: the SCORAD score, IGA, and the amount of steroids used per week. At this time, the microflora in the patient’s gut is also examined.

〇Manufacturing method of bacterial solution and other materials used for transplantation:
Dilute each 100 g of stool obtained from the donor with 600 mL of saline solution. The resulting solution is then filtered and concentrated by centrifugation. The resulting pellet is diluted with saline mixed with 20% glycerol. It is then sealed in capsules and stored at -80°C. For those used for placebo, only glycerol is diluted.

〇 About the donor:
Age ranged from 18 to 50 years old, and gender was male or female. They were in normal physical shape and none had taken antibiotics within 3 months.

【Impressions, etc.】

Currently, the clinical trial has just started and the results are not yet available.
What does “atopy” of atopic dermatitis mean? I looked it up and found the following:
“The word is derived from the Greek word ‘atopia,’ meaning ‘strange’ or ‘unfamiliar. It was named by Coca and Cooke in 1923 as an unusual hypersensitivity reaction that appeared in families or within families.”
(According to the website of the Gifu Pharmaceutical Association )

It is true that atopic dermatitis is a “strange” disease that repeatedly heals and worsens. The itching can cause insomnia, which is a troublesome aspect that reduces the patient’s quality of life.
Because of this, I look forward to the future results of FMT, a new treatment possibility that is not a drug.

Atopic dermatitis is a disease that many people deal with, but I had no idea about professional evaluation of the severity of the disease, so it was a good learning experience. Even though it is a disease in a nutshell, it must be evaluated objectively and appropriately in order to treat it.

I realized that there are many different diseases in the world, but each disease has its own evaluation method and symptom level, and doctors use these as the basis for selecting the drugs and treatments they prescribe to their patients.

*This posting is a redacted version of a study session for members of the Intestinal Flora Transplantation Clinical Study Group held online on May 8, 2021.