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

January 21, 2021
Gut Bacteria Papers and News

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

CLOSTRIDIOIDES  DIFFICILE INFECTION (CDI) IS A DISEASE.

The name is still not very familiar in Japan, but it has become quite a problem in Europe and the United States, where the number of patients is increasing dramatically and the fatality rate is high.

A few years ago, a ray of hope was lit for such CDI patients.
That is FMT.

IF YOU WATCH VIDEOS OF CDI PATIENTS IN THE U.S., NO ONE SAYS, “I CAN’T PUT STOOL IN.

Because lives are at stake.

 

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.

A STOOL BANK OF HEALTHY DONORS HAS BEEN ESTABLISHED AND, IN CONJUNCTION WITH ANIMAL EXPERIMENTS, A TREATMENT FOR CDI HAS ACTUALLY BEEN IMPLEMENTED.

The lightness of footwork in this area is very American, isn’t it?

 

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

Finally, the American Gastroenterological Association (AGA) has made a move.
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 the short and long term.

https://www.youtube.com/watch?v=RdRZUZ5uT2Q

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, 98% had undergone only one transplant.

However, 4% had 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, donor banks are 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?

I wrote in a past blog.
Why Clostridioides difficile Infections Are Not More Serious 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,
there must be many people in Japan who have lost their diversity because they have to use a lot of antibiotics, for example, or they have a lot of likes and dislikes.

There are many other diseases besides CDI that have been pointed out to be caused by a loss of intestinal bacterial diversity.
If FMT becomes readily available, it may be possible not only to treat these diseases but also to prevent them from occurring.

The Japanese really do have the intestinal bacteria to save the world.
I hope that American researchers will realize, “Japanese have less CDI?” and may they be inspired to use Japanese people as donors.