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Effectiveness of Femaltiker in Stimulation Lactation Among Mothers of Preterm Infants

NCT03341481 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2019-06-28

No results posted yet for this study

Summary

Femaltiker is a food for special medical purposes with a unique composition. Because beer, but not ethanol, has been reported in a number of studies to stimulate prolactin levels and breastmilk production, polysaccharide from barley was chosen as a potential galactogogue. To verify our assumption, a randomized, double blinded research with placebo was performed. The study was conducted according to good clinical practice and 10% of output data was audited by the outside monitor. The research was conducted from 14 April 2014 to 7 October 2015 in two NICUs with consent of the ethics committee on Medical Warsaw University.

Conditions

  • Lactation Induced

Interventions

OTHER

Femaltiker

Patient had taken twice a day the product

OTHER

Placebo

Patient had taken twice a day the placebo

Sponsors & Collaborators

  • Human Milk Bank Foundation

    collaborator UNKNOWN

  • Nutropharma LLC

    collaborator UNKNOWN

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Aleksandra Wesolowska, PhD · Warsaw Medical University, Department of Neonatology

  • Maria K. Borszewska-Kornacka, Prof. · Warsaw Medical University Hospital, Department of Neonatology and Intensive Care Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-10-31
Completion
2015-11-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03341481 on ClinicalTrials.gov