Alginate combined fecal microbiota transplantation for ulcerative colitis

JRCT ID: jRCTs031200103

Registered date:01/09/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative colitis
• Date of first enrollment: 01/09/2020
• Target sample size: 60
• Study type: Interventional

Intervention(s)

A-FMT plus algin acid therapy arm
Patients are performed Colonoscopy before participating in this clinical research and make sure the patients is eligible. Patient undergoes FMT two days after AFM therapy. Approximately 150 g to 200 g of fresh stool provided in advance from a donor is dissolved in 500 ml of physiological saline, and the treated stool that has been processed to remove excess residues and the like through a filter is stored frozen at minus 80 degree celsius. The diluted and filtered fecal suspension with dextrin added is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site. For the next 8weeks, patients take algin acid two times a day every single day.

A-FMT plus placebo arm
Patients are performed Colonoscopy before participating in this clinical research and make sure the patients is eligible. Patient undergoes FMT two days after AFM therapy. Approximately 150 g to 200 g of fresh stool provided in advance from a donor is dissolved in 500 ml of physiological saline, and the treated stool that has been processed to remove excess residues and the like through a filter is stored frozen at minus 80 degree celsius. The diluted and filtered fecal suspension with dextrin added is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site. For the next 8weeks, patients take Placebo two times a day every single day.

Outcome(s)

• Primary Outcome: Change of Total Mayo Score at the point of 8 weeks from baseline

Secondary Outcome

1.Change of Sum Endoscopic Mayo Score at the point of 8 weeks from baseline
2.Change of metagenome at the point of 8 weeks from baseline

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients
1.Eligible patients are active UC with a total Mayo score 15 of 3 to 10 points and a sum endoscopic mayo score of >=2.And they had exclusion diagnosis of infectious enterocolitis is done.
2.Ages 20 and over
3.Both gender
4.Hospitalized patients or outpatients.
5.Written and oral informed consent with a sufficient understanding.

Stool Donors
1.Healthy persons
2.20 year older
3.Both gender
4.A doctor interviews the donor candidate about the health condition, the past medical history, the life history, and the candidate answers correctly (those who refuse to answer are not allowed to participate)
5.The donor who the doctor judged that there is no problem in health condition will take the following examinations.
1)Fecal examination: The toxin (C. difficile toxin) and the pathogenic bacteria and parasites (general fecal culture, microscopic parasite egg inspection).
2) Blood test: hepatitis A, hepatitis B, hepatitis C, H IV antibody, HTLV antibody, syphilis (RPR / TP), cytomegalovirus antibody, ameba antibody, tuberculosis.
3) Saliva test: SARS-CoV-2 antigen.
4) Mental symptoms

The choice of donor will be made according to the needs of the patient. If a patient wishes a donor known by the investigator, the patient and the donor candidate will be present in front of the doctor confirming their will and sign the consent forms.

Exclude criteria

Patients
1.Patients using local therapy.
2.All cases with liver disease, kidney disease, heart disease and other serious complications, judged inappropriate by the attending doctor.
3.Cases with complications of other autoimmune diseases.
4.Nursing women, pregnant women and all cases with the possibility of pregnancy.
5.Patients with allergic diseases
6.Other cases judged inappropriate by the principal investigator.
7.Patients who were treated with antibiotics within three month

Stool Donors
1.Those from whom the informed consent is not obtained.
2.Cases suspected of the infectious diseases in inquiries, blood test and fecal examination screening or having a past disease to be excluded.
Excluded disease:
Inflammatory bowel disease, irritable bowel syndrome, chronic diarrhea, severe constipation, colonic polyps, colon cancer, autoimmune diseases, atopic dermatitis, severe obesity, chronic fatigue syndrome.
3.Other cases judged inappropriate by the principal investigator.
4.Donors who were treated with antibiotics within three month.
5.Donors who have a BMI of 30 or higher.

Related Information

• Primary Sponsor: Ishikawa Dai
• Source(s) of Monetary Support: Kirin Holdings Co.,Ltd