UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004143
Receipt number R000004975
Scientific Title An explorative study of T-FRAP analysis for intestinal flora and HGF level of GMA (granulocyte and monocyte absorption) for ulcerative colitis and Crohn's disease
Date of disclosure of the study information 2010/09/01
Last modified on 2015/04/10 16:44:45

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Basic information

Public title

An explorative study of T-FRAP analysis for intestinal flora and HGF level of GMA (granulocyte and monocyte absorption) for ulcerative colitis and Crohn's disease

Acronym

An explorative study of T-FRAP analysis for intestinal flora and HGF level of GMA (granulocyte and monocyte absorption) for ulcerative colitis and Crohn's disease

Scientific Title

An explorative study of T-FRAP analysis for intestinal flora and HGF level of GMA (granulocyte and monocyte absorption) for ulcerative colitis and Crohn's disease

Scientific Title:Acronym

An explorative study of T-FRAP analysis for intestinal flora and HGF level of GMA (granulocyte and monocyte absorption) for ulcerative colitis and Crohn's disease

Region

Japan


Condition

Condition

Ulcerative colitis and Crohn's disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare patients' intestinal flora with T-RFLP analysis about before and after GMA (granulocyte and monocyte absorption) for ulcerative colitis and Crohn's disease then to examine their disease activities. And to examine the efficacy of monitoring for changes of serum HGF level and disease activity.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary measurement is relationship between change of intestinal flora and disease activity at the end of the study. Clinical remission is defined as CAI<=4 for ulcerative colitis and CDAI<=150 for Crohn's disease.

Key secondary outcomes

1. Clinical response at the end of the study. Clinical response is defined as reduction of CAI more than 4 points for ulcerative colitis and CDAI more than 50 points for Crohn's disease
2. Reduction in CAI and CDAI
3. Reduction in CRP
4. Assessment for colonoscopic findings
5. Safety assessment


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Patients receive GMA treatment the maximum number of treatment allowed is eleven for ulcerative colitis.
Patients receive one GMA treatment per week and the maximum number of treatment allowed is ten for Crohn's disease.

Interventions/Control_2


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

16 years-old <

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Moderate, severe and fulminating active ulcerative colitis.
Nutrition therapy or conventional medication resistant Crohn's disease with large bowel lesion involvement.

Key exclusion criteria

1. Granulocyte count is equal to or less than 2,000/mm3
2. Serious infectious disease
3. Serious heart disease
4. Serious kidney disease
5. Hypotension (less than maximal blood pressure 80mmHg)
6. Pregnancy
7. Serious exsiccation / serious coagulation, serious anemia
8. Massive bleeding, perforation, toxic megacolon
9. Concomitant drug that would affect platelet function and coagulation system
10. Deep thrombophlebitis
11. Severe intestinal stricture that needs surgery
12. Previous surgery
13. Permanent stoma

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuyuki Fukuda

Organization

St. Luke's International Hospital

Division name

Department of Gastroenterology

Zip code


Address

9-1, Akashi-cho, Chuo-ku, Tokyo 104-8560 JAPAN

TEL

03-3541-5151

Email

fukukats@luke.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Katsuyuki Fukuda

Organization

St. Luke's International Hospital

Division name

Department of Gastroenterology

Zip code


Address

9-1, Akashi-cho, Chuo-ku, Tokyo 104-8560 JAPAN

TEL

03-3451-5151

Homepage URL


Email

fukukats@luke.ac.jp


Sponsor or person

Institute

St. Luke's International Hospital

Institute

Department

Personal name



Funding Source

Organization

JIMRO Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

聖路加国際病院(東京都)


Other administrative information

Date of disclosure of the study information

2010 Year 09 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

Terminated

Date of protocol fixation

2010 Year 04 Month 27 Day

Date of IRB


Anticipated trial start date

2010 Year 04 Month 01 Day

Last follow-up date

2011 Year 03 Month 01 Day

Date of closure to data entry

2011 Year 07 Month 01 Day

Date trial data considered complete

2011 Year 08 Month 01 Day

Date analysis concluded

2011 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 09 Month 01 Day

Last modified on

2015 Year 04 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004975


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name