UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010306
Receipt number R000012060
Scientific Title Efficacy and safety of a galactagogue containing Sylimarin and Galega in mothers of preterm infants
Date of disclosure of the study information 2013/03/25
Last modified on 2016/10/19 01:12:16

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Basic information

Public title

Efficacy and safety of a galactagogue containing Sylimarin and Galega in mothers of preterm infants

Acronym

Galactagogue usefulness in mothers of preterm infants

Scientific Title

Efficacy and safety of a galactagogue containing Sylimarin and Galega in mothers of preterm infants

Scientific Title:Acronym

Galactagogue usefulness in mothers of preterm infants

Region

Europe


Condition

Condition

prematurity

Classification by specialty

Pediatrics Nursing Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify efficacy and safety of a galactagogue containing Sylimarin and Galega in mothers of preterm infants during the first month of lactation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

To increase breast milk production by 25% in the treated arm compared with the placebo

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

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Food Other

Interventions/Control_1

Galactagogue administration from the 3rd to the 28th day of life

Interventions/Control_2

Placebo administration from the 3rd to the 28th day of life

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

gestational age between 27+0 and 32+6 weeks

Key exclusion criteria

breast milk contraindication, lactose intolerance

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Enrico Zecca

Organization

Catholic University of the Sacred Heart

Division name

Neonatology

Zip code


Address

Largo Gemelli 8, 00168 Rome, Italy

TEL

+39630154169

Email

enrizecca@rm.unicatt.it


Public contact

Name of contact person

1st name
Middle name
Last name Enrico Zecca

Organization

Catholic University of the Sacred Heart

Division name

Neonatology

Zip code


Address

Largo Gemelli 8, 00168 Rome, Italy

TEL

+39630154169

Homepage URL


Email

enrizecca@rm.unicatt.it


Sponsor or person

Institute

Division of Neonatology, Catholic University of the Sacred Heart

Institute

Department

Personal name



Funding Source

Organization

Division of Neonatology, Catholic University of the Sacred Heart

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2013 Year 03 Month 25 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.nature.com/ejcn/journal/v70/n10/full/ejcn201686a.html

Number of participants that the trial has enrolled


Results

50 mothers were included in each group. Milk production was significantly greater in the GG both at the 7th day of life and at the 30th day of life. The total production of milk during the study period was greater in the GG. No adverse reactions were noted in both the study groups. PiuLatte Plus increases milk production in mothers of preterm infants from the first days of treatment and throughout the first month of life without any significant side effects.

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

Completed

Date of protocol fixation

2013 Year 03 Month 25 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 15 Day

Last follow-up date

2015 Year 05 Month 31 Day

Date of closure to data entry

2015 Year 05 Month 31 Day

Date trial data considered complete

2015 Year 05 Month 31 Day

Date analysis concluded

2015 Year 07 Month 15 Day


Other

Other related information



Management information

Registered date

2013 Year 03 Month 22 Day

Last modified on

2016 Year 10 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012060


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name