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Large-scale stool transplant efficacy and safety study begins in the U.S.

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2021.01.21

A REPORT ON THE EFFICACY AND SAFETY OF INTESTINAL BACTERIA (FLORA) TRANSPLANTATION (FMT) WAS PUBLISHED IN THE UNITED STATES.

CLOSTRIDIOIDES DIFFICILE INFECTION (CDI) IS AN UNFAMILIAR NAME IN JAPAN. IN EUROPE AND THE UNITED STATES, THE NUMBER OF PATIENTS IS INCREASING DRAMATICALLY AND THE FATALITY RATE IS HIGH, MAKING IT A SIGNIFICANT PROBLEM.

A FEW YEARS AGO, A RAY OF HOPE WAS LIT FOR SUCH CDI PATIENTS.

THAT IS FMT.

FMT IS EFFECTIVE AGAINST CDI! SO FMT WAS POPULARIZED IN REAL PRACTICE BEFORE THE USUAL PROCESS OF CLINICAL TRIALS AND LONG-TERM FOLLOW-UP STUDIES.

SO FMT WAS POPULARIZED IN REAL PRACTICE BEFORE THE USUAL PROCESS OF CLINICAL TRIALS AND LONG-TERM FOLLOW-UP STUDIES.

The use of human-derived intestinal bacteria may have been a lower hurdle than other therapies in terms of safety.

APPLICATIONS HAVE BEEN TRIED FOR OTHER DISEASES SUCH AS ULCERATIVE COLITIS, CROHN’S DISEASE, ALLERGIES, AUTISM SPECTRUM DISORDERS, OBESITY, AND TYPE 2 DIABETES, BUT NONE HAVE YET TO WORK AS DRAMATICALLY AS CDI.

I wrote about this area in the article “Learning the Importance of Intestinal Bacterial Diversity from Clostridioides difficile Infection”.

Establishment of the Fecal Microbiota Transplantation National Registry

THEN THE AMERICAN GASTROENTEROLOGICAL ASSOCIATION (AGA) MOVED IN.

With funding from the National Institute of Allergy and Infectious Diseases, the Fecal Microbiota Transplantation National Registry was established to examine the efficacy and safety of FMT in both the short and long term.

THANKS TO THE RESPONSE RATE IN CDI AND THE ENVIRONMENT IN THE UNITED STATES, A COUNTRY THAT IS THE OPPOSITE OF “CONSERVATIVE,” FMT HAS PROGRESSED SO FAR.

AS THE OPENING STATEMENT STATES, “AIMING FOR A 10-YEAR FOLLOW-UP OF 4,000 PATIENTS,” ONE CAN SENSE THE SERIOUSNESS WITH WHICH THEY INTEND TO PUT FMT ON THE FOUNDATION OF MEDICAL COMMON SENSE.

FIRST 259 REPORTS RELEASED – 90% RESPONSE RATE AT 1 MONTH FOR CDI WITH FMT

The FMT National Registry has issued the first progress report for 259 patients.

Fecal Microbiota Transplantation Is Highly Effective in Real-World Practice: Initial Results From the FMT National Registry Gastroenterology

Kelly, C. R., Yen, E. F., Grinspan, A., Kahn, S. A., Atreja, A., Lewis, J. D., . . . Laine, L. (2020). 37 Fecal Microbiota Transplanation Is Highly Effective In Real-World Practice: Initial Results From The American Gastroenterological Association Fecal Microbiota Transplantation National Registry. Gastroenterology, 158(6). doi:10.1016/s0016-5085(20)30717-4

A summary of the results is quoted below.

Of the first 259 participants enrolled at 20 sites, 222 had completed short-term follow-up at 1 month and 123 had follow-up to 6 months; 171 (66%) were female. All FMTs were done for CDI and 249 (96%) used an unknown donor (eg, stool bank). One-month cure occurred in 200 patients (90%); of these, 197 (98%) received only 1 FMT. Among 112 patients with initial cure who were followed to 6 months, 4 (4%) had CDI recurrence. Severe symptoms reported within 1-month of FMT included diarrhea (n = 5 [2%]) and abdominal pain (n = 4 [2%]); 3 patients (1%) had hospitalizations possibly related to FMT. At 6 months, new diagnoses of irritable bowel syndrome were made in 2 patients (1%) and inflammatory bowel disease in 2 patients (1%).

Fecal Microbiota Transplantation Is Highly Effective in Real-World Practice: Initial Results From the FMT National Registry Gastroenterology

AMONG CDI PATIENTS, THE REMISSION RATE AFTER ONE MONTH WAS 90%. OF THESE, A WHOPPING 98% HAD UNDERGONE ONLY ONE TRANSPLANT.

However, 4% of the patients relapsed after 6 months.

ADVERSE EVENTS SUCH AS DIARRHEA AND ABDOMINAL PAIN ACCOUNTED FOR 2% EACH, AND 1% OF ALL ADVERSE EVENTS WERE “PROBABLY RELATED TO FMT”.

96% of donors use third-party flights from donor banks.

Unlike Japan, the donor bank is quite large.

Incidentally, the stool bank of the Intestinal Flora Transplant Clinical Research Group, with which Symbiosis Inc. has a technical affiliation, is as rigorous as Openbiome, the largest stool bank in the United States.

WHY IS IT SO DIFFICULT FOR FMT TO SPREAD IN JAPAN?

THIS IS BECAUSE CDI, WHICH IS COMPATIBLE WITH FMT, DOES NOT OCCUR FREQUENTLY IN JAPANESE.

BUT IF CDI IS CAUSED BY LOSS OF DIVERSITY, THEN

I have to use a lot of antibiotics.

Likes and dislikes.

There must be many people in Japan whose intestinal bacterial diversity is impaired by such factors as

ALTHOUGH DISEASES OTHER THAN CDI HAVE BEEN NOTED TO BE CAUSED BY IMPAIRED INTESTINAL BACTERIAL DIVERSITY

IF FMT BECOMES READILY AVAILABLE, IT MAY BE POSSIBLE NOT ONLY TO TREAT THESE DISEASES BUT ALSO TO PREVENT THEM.

I think the Japanese really do have the intestinal bacteria to save the world.

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