UMIN-CTR Clinical Trial

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	Japan

Condition
Condition	Ulcerative Colitis
Classification by specialty	Gastroenterology
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.
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	Food Maneuver
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.
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
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.
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
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Dai Middle name Last name Ishikawa
Organization	Juntendo University Hospital
Division name	Gastroenterology
Zip code	113-8431
Address	3-1-3 Hongo,Bunkyo-ku,Tokyo
TEL	03-3813-3111
Email	dai@juntendo.ac.jp

Public contact
Name of contact person	1st name Koki Middle name Last name Okahara
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
Email	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

Other related organizations
Co-sponsor
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
Email	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

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2020 Year 08 Month 14 Day
Date of IRB	2020 Year 08 Month 25 Day
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 01 Day
Last modified on	2020 Year 10 Month 01 Day

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

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