Unique ID issued by UMIN | UMIN000041968 |
---|---|
Receipt number | R000047906 |
Scientific Title | Single center randomized study: Alginate combined fecal microbiota transplantation for ulcerative colitis |
Date of disclosure of the study information | 2020/10/01 |
Last modified on | 2020/10/01 18:46:42 |
Single center randomized study: Alginate combined fecal microbiota transplantation for ulcerative colitis
FLAG study
Single center randomized study: Alginate combined fecal microbiota transplantation for ulcerative colitis
Single center randomized study: Alginate combined fecal microbiota transplantation for ulcerative colitis
Japan |
Ulcerative Colitis
Gastroenterology |
Others
NO
Explore the effect of fecal microbiota transplantation therapy with antibiotics colitis and addition of alginate for ulcerative colotis.
Efficacy
Change of Total Mayo Score at the point of 8 weeks from baseline
Interventional
Parallel
Randomized
Cluster
Double blind -all involved are blinded
Placebo
2
Treatment
Food | Maneuver |
AFMT plus colecut 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 do nor 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 20 degree celsius. The diluted and filtered fecal suspension is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site.
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 2 00 g of fresh stool provided in advance from a do nor is dissolved in 500 ml of physiological saline, and the treated stool that has been processed to 8 remove excess residues and the like through a filter is stored frozen at minus 20 degree celsius. The diluted and filtered fecal suspension is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site.
AFMT plus colecut therapy arm.
For the next 8weeks, patients take Colecut two times a day every single day.
AFMT plus placebo arm.
For the next 8weeks, patients take Placebo two times a day every single day.
20 | years-old | <= |
Not applicable |
Male and Female
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 (t hose 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 (genera l fecal culture, microscopic parasite egg inspection).
2) Blood test: hepatitis A, hepatitis B, hepatitis C, HIV antibody, HTLV antibody, syphilis (RPR / TP), 5 cytomegalovirus antibody, ameba antibody, tuberculosis, COVID19 antibody. 3) 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 do nor candidate will be present in front of the doctor confirming their will and sign the consent forms.
Patients
1.Patients using local therapy.
2.All cases with liver disease, kidney disease, hear t 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 months
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 months
60
1st name | Dai |
Middle name | |
Last name | Ishikawa |
Juntendo University Hospital
Gastroenterology
113-8431
3-1-3 Hongo,Bunkyo-ku,Tokyo
03-3813-3111
dai@juntendo.ac.jp
1st name | Koki |
Middle name | |
Last name | Okahara |
Juntendo University Hospital
Gastroenterology
113-8431
3-1-3 Hongo,Bunkyo-ku,Tokyo
03-3813-3111
k-okahara@juntendo.ac.jp
Juntendo University
Joint Research
Other
Juntendo university hospital
3-1-3 Hongo,Bunkyo-ku,Tokyo
03-5802-1584
crbjun@juntendo.ac.jp
NO
2020 | Year | 10 | Month | 01 | Day |
Unpublished
Open public recruiting
2020 | Year | 08 | Month | 14 | Day |
2020 | Year | 08 | Month | 25 | Day |
2020 | Year | 10 | Month | 01 | Day |
2024 | Year | 12 | Month | 31 | Day |
2020 | Year | 10 | Month | 01 | Day |
2020 | Year | 10 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047906
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |