臨床研究等提出・公開システム

Specified clinical trial for fecal microbiota transplantation and gut microbiota reconstruction in patients with refractory diarrhea

Handai FMT study

10

Infectious diseases (n=4), gastrointestinal diseases (n=3), malignant diseases (n=2), immune diseases (n=1)

FMT was performed in 10 cases in accordance with protocol, and the observation period has ended.

The main adverse events were COVID-19 and fever, each occurring in two cases, and nausea, reflux, and abdominal pain, each occurring in one case. One case of sepsis was observed as a serious adverse event, but no causal relationship was determined.

Regarding the primary endpoint about safety, adverse events were within the expected range, and it was determined that FMT could be performed safely. The secondary endpoints are summarized below. 1. Changes in stool shape (Bristol classification):Stool shape improved significantly after FMT. 2. Changes in bowel movement frequency: Bowel movement frequency improved significantly after FMT. 3. Changes in stool volume: Stool volume decreased significantly. 4. Changes in gut microbiota: Bacteroidetes in stool significantly increased significantly. 5. Changes in hematological tests and blood inflammatory biomarkers: No significant differences were observed in LRG, IL-6, or CRP, but IL-6 tended to decrease.

FMT was safely performed in patients with refractory diarrhea. FMT also improved diarrhea symptoms. Future research directions include securing insurance coverage in Japan for FMT targeting Clostridioides difficile (CD) infections, which have demonstrated favorable treatment outcomes both globally and in this study. Furthermore, beyond CD infections, advancing FMT treatment based on diagnostic criteria for gut dysbiosis or antibiotic-associated diarrhea targeting refractory diarrhea could be a target.

Dec. 01, 2025

No

none

https://jrct.mhlw.go.jp/latest-detail/jRCTs051220110

Shimizu Kentaro

Osaka University Hospital

2-15 Yamadaoka, Suita, Osaka

shimiken@hp-emerg.med.osaka-u.ac.jp

Shimizu Kentaro

Osaka University Hospital

2-15 Yamadaoka, Suita, Osaka

+81-6-6879-5111

shimiken@hp-emerg.med.osaka-u.ac.jp

Complete

Oct. 26, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Study subject:
(1) Aged 18 years or older at informed consent.
(2) Patient with prolonged diarrhea more than 10 days despite of standard treatment for diarrhea, or who continue to have diarrhea without using antidiarrheal drugs.
(3) Patient with dysbiosis in the gut assessed using stool smear.
(4) Patient with written consent to participate in this study from the patient or his/her surrogate.

Donor:
(1) Aged 18-70 years (If possible, relatives of the study subject).
(2) Patient without dysbiosis in the gut assessed using stool smear.
(3) If the study subject has a food allergy, person who is possible not to consume the food for at least 5 days before stool collection.
(4) Person with written consent from the person regarding the implementation of interview and various tests specified in this study and the provision of stool.

Study subject:
(1) Patient with shock (blood lactate level 18 mg/dL or higher) or who using catecholamines.
(2) Patient with severe immunodeficiency <500 / microL of neutrophils.
(3) Patient who cannot expect a prognosis of 3 months or more even if diarrhea have subsided.
(4) Patient who are judged by the investigator to be inappropriate as research subjects for other reasons.

Donor:
(1) Person suspected to have infection by interviewing and screening for blood and stool tests, or who have disease that should be excluded.
Excluded diseases: inflammatory bowel disease, irritable bowel syndrome, chronic diarrhea, severe constipation, malignant tumor under treatment, autoimmune disease, severe obesity, Parkinson's disease, autism, depression, Creutzfeldt-Jakob's disease.
For cytomegalovirus and EB virus, when the study subject is not infected, if the donor's screening test result is positive, it is non-eligible.
(2) Parson who are judged by the investigator to be inappropriate as doner for other reasons

Both

Refractory diarrhea

Receive about 50 g or more of stool from the donor at screening test, dilute it 3 to 4 times with saline and mix. Centrifuge and filter, and finally consolidate to 200-300 ml.
Store frozen until FMT is performed, and perform FMT after thawing.
The route of administration is the ileocecal region with a colonoscope.

Adverse events

(1) Changes in stool shape (Bristol classification)
(2) Changes in stool frequency
(3) Changed in stool volume
(4) Changes in gut microbiota (stool smear / culture, genome)
(5) Changes in hematological tests and blood inflammation biomarkers

+81-6-6210-8296

Oct. 14, 2022

none