Fecal microbiota transplantation for intractable gastrointestinal diseases (FEMIGI study)

JRCT ID: jRCTs041190021

Registered date:23/04/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: 1)Clostridium difficile infection 2)Crohn disease, ulcerative colitis 3)Chronic Enteropathy associat
• Date of first enrollment: 23/04/2019
• Target sample size: 50
• Study type: Interventional
• Intervention(s): fecal microbiota transplatation

Outcome(s)

• Primary Outcome: Safety in FMT
• Secondary Outcome: The effectiveness and acceptance of FMT

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1)recipient
A patient who provides the informed consent or legally acceptable representatives of whom provide the informed consent
(2)donor
with all negative screening tests

Exclude criteria

(1)recipient
1) past history of allergy to drugs used in this study
2) possible of documented pregnant women
3) judged to be inappropriate by the investigator
(2)donor
1) person who is not compatible to the selection criteria
2) person with past history of allergy to drugs used in this study
3) possible of documented pregnant women
4) person with suspected or documented bowel obstruction
5) person with gastrointestinal tumors
6) person who was judged to be inappropriate

Related Information

• Primary Sponsor: Ohmiya Naoki
• Source(s) of Monetary Support: Contributions for the specific public interest