Handai FMT study

JRCT ID: jRCTs051220110

Registered date:26/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Refractory diarrhea
• Date of first enrollment: 06/06/2023
• Target sample size: 10
• Study type: Interventional

Intervention(s)

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.
In principle, the route of administration is the ileocecal region with a colonoscope. Administration to the duodenum and beyond by the nasal tube or enterostomy tube is also acceptable, depending on whether the research subject is infected with SARS-CoV-2 or the condition of the intestinal tract,.

Outcome(s)

• Primary Outcome: Adverse events

Secondary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Shimizu Kentaro