UMIN-CTR Clinical Trial

Public title

Double-blind, randomized, controlled trial of the effects of probiotics for chemotherapy-induced gastrointestinal mucositis

Acronym

Study the effectiveness of probiotics for chemotherapy-induced gastrointestinal mucositis

Scientific Title

Double-blind, randomized, controlled trial of the effects of probiotics for chemotherapy-induced gastrointestinal mucositis

Scientific Title:Acronym

Study the effectiveness of probiotics for chemotherapy-induced gastrointestinal mucositis

Region

Japan

Condition

Multiple Myeloma

Classification by specialty

Hematology and clinical oncology

Infectious disease

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We will consider whether it is possible to reduce bacterial translocation due to chemotherapy-induced gastrointestinal mucositis with hematological malignancies by B. breve, which is one of the probiotics.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

bacterial rRNA-targeted reverse transcription-quantitative PCR(BrRNA RT-PCR)

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

B.breve administered orally three times a day. Continued until three weeks after the start of the chemotherapy two weeks before the start of chemotherapy.
Collected blood and stool at 2 weeks before the start of chemotherapy, treatment start date, on fever, a total of three times.

Interventions/Control_2

placebo administered orally three times a day. Continued until five weeks after the start of the chemotherapy two weeks before the start of chemotherapy.
Collected blood and stool at 2 weeks before the start of chemotherapy, treatment start date, on fever, a total of three times.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Adult patients admitted to the hospital
for treatment with auto-PBSCT in order to be diagnosed with multiple myeloma in Department of Hematology Juntendo University School of medicine.

Key exclusion criteria

1.Patient who has a colostomy and gastrostomy.
2.Patient being treated has a collagen disease such as immune dysfunction.
3.Patient being treated has a cranial nerve dysfunction or heart failure during treatment.
4.Patients with more than two weeks, the oral administration of probiotics before the start of this clinical research.
5.Patients not undergoing cryotherapy
6.If the the attending physician has determined inappropriate to participate in this study.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Komatsu Norio

Organization

Juntendo University School of medicine.

Division name

Department of Hematology.

Zip code

Address

1-3 3-chome, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-5802-1069

Email

komatsun@juntendo.ac.jp

Name of contact person

1st name
Middle name
Last name	Sakurai Hiroko

Organization

Juntendo University School of medicine.

Division name

Department of Hematology.

Zip code

Address

1-3 3-chome, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-5802-1069

Homepage URL

Email

hiiduka@juntendo.ac.jp

Institute

Department of Hematology. Juntendo University School of medicine.

Institute

Department

Personal name

Organization

Department of Hematology Juntendo University School of medicine.
Division of Laboratory for Probiotic Research

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Kabushiki-gaisha Yakuruto Honsha

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

03

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2013

Year

02

Month

19

Day

Date of IRB

Anticipated trial start date

2013

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

03

Month

10

Day

Last modified on

2013

Year

11

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011949