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OpenTrials
Completed

NCT Number: NCT03341481

Effectiveness of Femaltiker in Stimulation Lactation Among Mothers of Preterm Infants

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Human Milk and Lactation Research at Regional Human Milk Bank in Holy Family Hospital, Warsaw, Poland

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About this study

The traget population consisted of volunteers women who delivered infants at < 37 weeks gestation. Criteria of exclusion were: hypothyroidism and diabetes type I or II diagnosed and treated before pregnancy.

The schedule of the study included three visits with in certain point time during two weeks postpartum. During the study patients had taken twice a day product or placebo, respectively. The protocol of the study included :

  • Three consecutive blood collections for examination of prolactin level on every visit (10 min beforeBlood examination of prolactin level in triplet on every visit (10 min before breastfeeding session, 10 min after beginning of breastfeeding and 10 min. after finishing of breastfeeding.)
  • Filling pumping log to control variation in the milk yield and efficacy of lactation.
  • Measurement of the volume of milk producing before blood examination (directly in case of pumping by the mother or indirectly based on weight of the baby before and after feeding)
  • Interview with lactation consultant concerning patient's self-estimation of lactation efficacy Data collection was done using the CRF in the paper form which were then put tto the database in ExcelDocuments.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • mothers of preterm infants (born before 37 completed weeks of pregnancy)

Exclusion criteria

  • hypothyroidism
  • diabetes type I or II diagnosed and treated before pregnancy
  • participating in other study

Treatment and study plan

Femaltiker

Other

Patient had taken twice a day the product

Other names: LACTANELL formula

Placebo

Other

Patient had taken twice a day the placebo

Primary outcomes

  1. The volume of milk produced by study participants

    Time frame: two weeks after delivery

    Measurement of the volume of expressed milk

  2. Level of serum prolactin

    Time frame: two weeks after delivery

    Three consecutive blood collections for prolactin level

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Collaborators

  • Human Milk Bank Foundation
  • NutroPharma

Registry information

Official study title

Effectiveness of a Dietary Supplement Femaltiker in Improvement of Initiation and Stimulation Lactation Among Mothers of Preterm Infants

Acronym: FEMA

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 14, 2017
Registry last updated
Jun 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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