FMT for gastrointestinal symptoms associated with dysbiosis

JRCT ID: jRCTs051240206

Registered date:09/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastrointestinal symptoms associated with dysbiosis
• Date of first enrollment: 09/12/2024
• Target sample size: 80
• Study type: Interventional

Intervention(s)

Method of FMT:
At the time of the screening test, the donor provides approximately 50 g or more of stool, which is diluted 3-4 times with saline solution and mixed. After centrifugation and filtration, adjust the glycerol to about 10% of the total volume and finally consolidate to 200-300 ml, store frozen until FMT is performed, and perform FMT after thawing. Additionally, glycerol is added to regulate osmotic pressure and increase the survival rate of gut bacteria.
In principle, the solution should be administered via the ileum using a colonoscope. However, if deep insertion into the ileum is difficult, it can also be administered into the or colon/rectum. If the colon is postoperative, it can also be administered into colon/rectum, via a transanal endoscope into the small intestine, or through a colorectal stoma.

FMT group:
FMT is performed as the first dose.

Control group:
Saline solution is administered as the first dose. FMT is performed for the study subjects with remaining gastrointestinal symptoms at their request after the end of the post-observation period (28 days).

In both groups, a second FMT may be performed at the request of the study subjects if the initial FMT was not sufficiently effective.

Outcome(s)

• Primary Outcome: Change in overall gastrointestinal symptoms at Day 28 of the first dose (FMT or saline) from baseline (Day-7 to Day 0)

Secondary Outcome

(1) Change in individual gastrointestinal symptoms (abdominal pain, diarrhea, bloating, constipation) at Day 28 of the first dose from baseline
(2) Change in Irritable Bowel Syndrome Symptom Severity Scale at Day 28 of the first dose from baseline
(3) Change in intestinal microbiota at Day 28 of the first dose from baseline
(4) Adverse events
(5) Change in quality of life at Day 28 of the first dose from baseline
(6) Change in psychiatric symptoms (depression and anxiety) at Day 28 of the first dose from baseline
(7) Assessment of stratification by background disease (enteritis or non-enteritis)
(8) Change in clinical symptoms (change in clinical score, change in biomarkers) in patients with inflammatory bowel disease

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 who has gastrointestinal symptoms (abdominal pain, diarrhea, bloating, or constipation) caused by or as a result of treatment for the underlying disease, and whose symptoms persist for more than 10 days despite standard treatment.
(3) Patient with dysbiosis in metagenomic analysis of the intestinal microbiota.
(4) Patient with written consent to participate in this study from the patient.

Donor:
(1) Aged 18-70 years (If possible, relatives of the study subject).
(2) Parson without dysbiosis in metagenomic analysis of the intestinal microbiota.
(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) Patient with shock 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 gastrointestinal symptoms have subsided.
(4) Patient with small bowel stoma.
(5) Patient who have had FMT within the past year from the date of consent.
(6) Patient with severe underlying inflammatory bowel disease (full Mayo score of 11 or more points for ulcerative colitis, Crohn's disease activity index of 451 or more points for Crohn's disease)
(7) Pregnant woman, woman who may be pregnant, woman who wish to become pregnant between the time consent is obtained and the time FMT is performed, and woman who are unable to agree on an appropriate method of contraception (intrauterine device, pessary or partner compliance with condom use)
(8) Patient with severe food allergies.
(9) 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 (BMI 35 or more), 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: Takehara Tetsuo
• Secondary Sponsor: Yoshihara Takeo