Handai FMT study

Not Applicable

Recruiting

• Conditions: Refractory diarrhea

• Registration Number: JPRN-jRCTs051220110
• Lead Sponsor: Shimizu Kentaro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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.

Exclusion Criteria

Study subject:
(1) Patients with circulatory failure of shock.
(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

Study & Design

• Study Type: Interventional
• Study Design: Not specified