UMIN-CTR Clinical Trial

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

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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 or person

Institute

Juntendo University

Institute

Department

Personal name



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

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