UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010089
Receipt number R000011814
Scientific Title Effect of bifidobacterium enema in very low birth weight infants - double-blind controlled trial of enema vs enteral administration-
Date of disclosure of the study information 2013/02/21
Last modified on 2016/11/13 08:12:20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effect of bifidobacterium enema in very low birth weight infants - double-blind controlled trial of enema vs enteral administration-

Acronym

Effect of bifidobacterium enema in very low birth weight infants

Scientific Title

Effect of bifidobacterium enema in very low birth weight infants - double-blind controlled trial of enema vs enteral administration-

Scientific Title:Acronym

Effect of bifidobacterium enema in very low birth weight infants

Region

Japan


Condition

Condition

Very low birth weight infants

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Low birth weight infants have immature digestive function. We have hypothesized that many live bacteria are died when enteral probiotics administration supplied to reach anus. Probiotics enema in very low birth weight infants may have better than a conventional enteral administration. In order to clarify these, we planned this study.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Bacterial flora in the stool (1W-4W after bifidobacterium administration)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

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

Interventions/Control_1

Gastric (placebo*)
Enema (bifidobacterium**)
*Placebo(bifidobactirum free, 3 times/day)
**Bifidobacterium(bifidobacterium. breve 1.5*10*9 cfu/dose, 3 times/day)

Interventions/Control_2

Gastric (bifidobacterium**)
Eenema (placebo*)

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Very low birth weignt infants

Key exclusion criteria

Congenital anomaly, immunodeficiency

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukiko Motojima, Shoichi Ezaki, Yosuke Sudo

Organization

Saitama Medical Center, Saitama Medical University

Division name

Neonatal Medicine, Center for Maternal, Fetal and Neonatal Medicine

Zip code


Address

1981 Kamoda, Kawagoe, Saitama

TEL

049-228-3890

Email

s_ezaki@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yukiko Motojima

Organization

Saitama Medical Center, Saitama Medical University

Division name

Neonatal Medicine, Center for Maternal, Fetal and Neonatal Medicine

Zip code


Address

1981 Kamoda, Kawagoe, Saitama

TEL

042-228-3727

Homepage URL


Email

y_mtjm@saitama-med.ac.jp


Sponsor or person

Institute

Neonatal Medicine, Center for Maternal, Fetal and Neonatal Medicine, Saitama Medical Center, Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

Research and information Center of Morinaga Milk


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



Other administrative information

Date of disclosure of the study information

2013 Year 02 Month 21 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

Enrolling by invitation

Date of protocol fixation

2013 Year 02 Month 21 Day

Date of IRB


Anticipated trial start date

2013 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 02 Month 21 Day

Last modified on

2016 Year 11 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011814


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name