Effectiveness of Femaltiker in Stimulation Lactation Among Mothers of Preterm Infants

Lactation Induced Clinical Trial

— FEMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341481
• Other study ID #: FEMA/01/2014
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2017
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lactation Induced

Intervention

Other:
• Femaltiker
Patient had taken twice a day the product
• Placebo
Patient had taken twice a day the placebo

Locations

Country	Name	City	State
Poland	Laboratory of Human Milk and Lactation Research at Regional Human Milk Bank in Holy Family Hospital	Warsaw
Poland	Mother and Child Health Center of Warsaw Medical University	Warsaw
Poland	Warsaw Medical University - Clinic of Neonatology	Warsaw
Poland	Warsaw Medical University Hospital	Warsaw

Sponsors (4)

Lead Sponsor	Collaborator
Medical University of Warsaw	Human Milk Bank Foundation, Nutropharma LLC, University Health Center of Woman and Child, Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The volume of milk produced by study participants	Measurement of the volume of expressed milk	two weeks after delivery
Primary	Level of serum prolactin	Three consecutive blood collections for prolactin level	two weeks after delivery