Basic Research on Microbiome Bank for Manufacturing and Management of Standardized Safe FMT Suspension

Basic Research on Microbiome Bank for Manufacturing and Management of Standardized Safe FMT Suspension - Basic Research on Microbiome Bank

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049692

Enrollment

Registered

2022-12-05

Start date

2022-06-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorders Associated With Dysbiosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) healthy subjects aged >= 18 years at the time of informed consent; (2) Those who are able to donate regularly. (3) Those who are able to undergo regular interviews and screening tests(blood test, stool test, saliva test). (4) Those who are judged to be eligible in the interview about their health status, medical history, treatment history, vaccination history, and history of high-risk behavior. (5) Those who have the ability to give consent and can obtain written consent of their own free will.

Exclusion criteria

Exclusion criteria: (1) Suspected infection or carriage of viruses, bacteria, or parasites with the following pathogenicity: Hepatitis A virus, Hepatitis B virus, Hepatitis C virus, Hepatitis E virus, HIV-1, 2, HTLV-1, Cytomegaloviruses, EB virus, Lues, M. tuberculosis, Clostridioides difficile, Enterohemorrhagic E. coli (O-157), enteroaggregative Escherichia coli (EAEC), Enteropathogenic E. coli (EPEC), Enterotoxigenic E. coli (ETEC), Shiga toxin-producing E. coli (STEC), enteroinvasive Escherichia coli (EIEC), Salmonella, Shigella, Yersinia, Campylobacter, Vibrio parahaemolyticus, Vibrio cholerae, Vibrio vulnificus, Pregenomonas shigeloides, Drug-resistant bacteria, Adenovirus, Norovirus, Rotavirus, Astrovirus, Sapovirus, SARS-CoV-2, Parasites (Strongyloides stercoralis, Giardia lamblia, Cryptosporidium, Entamoeba histolytica, Cyclospora, and other oocysts and parasites) (2) Those who deviated from the reference values of general peripheral blood test, creatinine, C-reactive protein, AST, ALT, ALP, total bilirubin, and albumin in blood test. (3) Those who have a positive fecal blood test result from a fecal hemoglobin test. (4) Persons deemed unsuitable as research subjects by the principal (sub) investigator.

Design outcomes

Primary

Measure	Time frame
-	—

Countries

Japan

Contacts

Public ContactDai Ishikawa

Juntendo University Hospital Department of Gastroenterology

dai@juntendo.ac.jp03-3813-3111

Outcome results