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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010306
Receipt No. 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

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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
Institute Division of Neonatology, Catholic University of the Sacred Heart
Institute
Department

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
URL(English) https://upload.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


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