UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of bifidobacterium enema in very low birth weight infants - double-blind controlled trial of enema vs enteral administration-
Title of the study (Brief title)	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	Yukiko Motojima, Shoichi Ezaki, Yosuke Sudo
Organization	Saitama Medical Center, Saitama Medical University
Division name	Neonatal Medicine, Center for Maternal, Fetal and Neonatal Medicine
Address	1981 Kamoda, Kawagoe, Saitama
TEL	049-228-3890
Email	s_ezaki@saitama-med.ac.jp

Public contact
Name of contact person	Yukiko Motojima
Organization	Saitama Medical Center, Saitama Medical University
Division name	Neonatal Medicine, Center for Maternal, Fetal and Neonatal Medicine
Address	1981 Kamoda, Kawagoe, Saitama
TEL	042-228-3727
Homepage URL
Email	y_mtjm@saitama-med.ac.jp

Sponsor
Institute	Neonatal Medicine, Center for Maternal, Fetal and Neonatal Medicine, Saitama Medical Center, Saitama Medical University
Institute
Department

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

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 02 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011814