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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000041968 |
Receipt No. | 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 |
Basic information | ||
Public title | Single center randomized study: Alginate combined fecal microbiota transplantation for ulcerative colitis | |
Acronym | FLAG study | |
Scientific Title | Single center randomized study: Alginate combined fecal microbiota transplantation for ulcerative colitis | |
Scientific Title:Acronym | Single center randomized study: Alginate combined fecal microbiota transplantation for ulcerative colitis | |
Region |
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Condition | ||
Condition | Ulcerative Colitis | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Explore the effect of fecal microbiota transplantation therapy with antibiotics colitis and addition of alginate for ulcerative colotis.
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Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Change of Total Mayo Score at the point of 8 weeks from baseline |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Cluster |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |||
No. of arms | 2 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | 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. |
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Interventions/Control_2 | 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. |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion 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 (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. |
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Key exclusion criteria | 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 |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Juntendo University Hospital
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Division name | Gastroenterology | ||||||
Zip code | 113-8431 | ||||||
Address | 3-1-3 Hongo,Bunkyo-ku,Tokyo | ||||||
TEL | 03-3813-3111 | ||||||
dai@juntendo.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Juntendo University Hospital | ||||||
Division name | Gastroenterology | ||||||
Zip code | 113-8431 | ||||||
Address | 3-1-3 Hongo,Bunkyo-ku,Tokyo | ||||||
TEL | 03-3813-3111 | ||||||
Homepage URL | |||||||
k-okahara@juntendo.ac.jp |
Sponsor | |
Institute | Juntendo University |
Institute | |
Department |
Funding Source | |
Organization | Joint Research |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Juntendo university hospital |
Address | 3-1-3 Hongo,Bunkyo-ku,Tokyo |
Tel | 03-5802-1584 |
crbjun@juntendo.ac.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | Open public recruiting | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.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 |