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

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…

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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  • 城谷昌彦医師|IBS・潰瘍性大腸炎のQOLを変えるFMT治療の現在地

    日々の診療の中で、従来の標準治療だけでは十分に対応しきれない慢性的な消化器疾患。特に、潰瘍性大腸炎や過敏性腸症候群(IBS)を患う人々は、検査数値や画像所見だけでは見えにくい深い不安と、生活上の大きな制限を抱え続けている。 城谷バイオウェルネスクリニックの城谷昌彦医師が「腸内フローラ移植(FMT)」という新たな治療領域に関心を持った大きなきっかけ―――それは、他でもない先生自身が回腸嚢炎の治療法の一つとしてFMTを自ら受けた経験にあった。 自ら患者としてFMTを体験した医師は、臨床でNanoGAS®-FMT(水素ナノバブル水を用いた腸内フローラ移植)をどう活かし、患者の人生をどう変えているのか。そして、なぜ今、期待ばかりをあおることなく「慎重なエビデンスの検証」を訴え続けるのか。 「医療の成果は、単に症状や検査数値の改善だけではありません。患者さんが本来取り組みたかったことに再び向き合えるようになること、将来に前向きな気持ちを持てるようになることこそが、非常に大切な成果なのです。」 城谷医師の医療哲学と、2026年9月に開催される「第10回 一般財団法人腸内フローラ移植臨床 学術大会」に向けた見どころに迫る。 数値や画像には映らない「患者の不安」に向き合う 自らがFMTを受けた経験―――腸内細菌という「切り札」 「私自身、回腸嚢炎に対する治療法の一つであるFMTを大学の治験を通じて受けたことが、腸内フローラ移植に関心を持つ大きなきっかけでした」と、自らの患者体験と、消化器専門医としての深い葛藤を振り返る。 日々の診療において、従来の標準治療だけではどうしても対応しきれない患者の症状や経過に向き合うことは決して少なくない。中でも、潰瘍性大腸炎やIBS(過敏性腸症候群)の患者は、内視鏡検査や血液検査の数値だけでは測れない「いつお腹が痛くなるか分からない」「外出や外食が怖い」といった日常生活上の制限や精神的な不安を常時抱えている。 「腸内フローラを整えることは、単なる消化器症状の改善にとどまらず、患者さんのQOL(生活の質)を根本から向上させる可能性を秘めている」。自らの体験と臨床での実感から、腸内細菌へのアプローチを従来の治療を補完する「切り札」の一つとして見出すようになった。 NanoGAS®-FMTという新たな選択肢の可能性 大学の治験でFMTを受けたものの、大きな改善は見られなかったが、その可能性を感じることはできたという。数あるFMTの中でNanoGAS®-FMTを導入した理由は、「臨床現場での扱いやすさ」と「患者への負担軽減」にあったという。 従来の移植法と比較しても、患者への心身の負担に配慮しながら実施できる可能性を感じたことが大きな決定打となった。これまで既存の治療法を試しても十分な改善が得られなかった患者に対して、「腸内環境の再構築」という全く新しい選択肢を提示できるようになった意義は極めて大きい。 しかし、城谷医師は戒めを忘れない。 「一方で、FMTを『万能の治療法』のように扱うべきではないとも考えています。すべての患者さんに同じ結果が出るわけではありませんし、適応の見極め、既存治療との組み合わせ、そして治療前後の評価は極めて慎重に行う必要があります」 将来への不安を抱えた若い潰瘍性大腸炎患者の劇的な変化…

If you are concerned about your intestinal flora, start by consulting us.

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