Lactation InducedFEMANCT03341481
Effectiveness of Femaltiker in Stimulation Lactation Among Mothers of Preterm Infants
A study testing Femaltiker in people with Lactation Induced, run by Medical University of Warsaw at 4 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation Induced
- What is being tested?
- Femaltiker
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 4 sitesPoland
- Study dates
- Apr 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- mothers of preterm infants (born before 37 completed weeks of pregnancy)
Who cannot join
- hypothyroidism
- diabetes type I or II diagnosed and treated before pregnancy
- participating in other study
Trial locations and contacts
4 sites in 1 country.
Poland4 sites
Warsaw Medical University Hospital
Warsaw, 00315
Mother and Child Health Center of Warsaw Medical University
Warsaw, 02015
Laboratory of Human Milk and Lactation Research at Regional Human Milk Bank in Holy Family Hospital
Warsaw, 02091
Warsaw Medical University - Clinic of Neonatology
Warsaw, 02091
About this study
Official title: Effectiveness of a Dietary Supplement Femaltiker in Improvement of Initiation and 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.
Read the detailed 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.
- Conditions
- Lactation Induced
- Being tested
- Femaltiker, Placebo
- Keywords
- galactagogues, lactogenesis, preterm labor
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemaltikerOther
Also called LACTANELL formula
Patient had taken twice a day the product
PlaceboOther
Patient had taken twice a day the placebo
| Study group | Role | What they receive |
|---|---|---|
| Femaltiker | Experimental | 7.7 g of Femaltiker twice a day for 14 days of the trial. Receives: Other: Femaltiker |
| placebo | Placebo comparator | 7.7 g placebo 14 days of the trial. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The volume of milk produced by study participants
Measurement of the volume of expressed milk
Measured: two weeks after delivery
Level of serum prolactin
Three consecutive blood collections for prolactin level
Measured: two weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study startApr 2014
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactation InducedStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment was given to the mothers assigned to the galactogogue group, whereas a placebo was given to those assigned to the placebo group. Each patient randomized to either treatment or placebo group received 28 sachets for 14 days of the trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Human Milk Bank Foundation, NutroPharma
- Responsible party
- Principal investigator, Maria Katarzyna Kornacka, Medical University of Warsaw
- Investigators
- Aleksandra Wesolowska, PhD, Study director, Warsaw Medical University, Department of NeonatologyMaria K. Borszewska-Kornacka, Prof., Principal investigator, Warsaw Medical University Hospital, Department of Neonatology and Intensive Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341481
- Sponsor's protocol ID
- FEMA/01/2014
- Acronym
- FEMA
- Status last verified
- Nov 2017
- First submitted
- 23 Mar 2017
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Dietary Supplement Femaltiker in Improvement of Initiation and Stimulation Lactation Among Mothers of Preterm Infants
- ClinicalTrials.gov ID
- NCT03341481
- Acronym / sponsor ID
- FEMA / FEMA/01/2014
- Conditions
- Lactation Induced
- Keywords
- galactagogues, lactogenesis, preterm labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Human Milk Bank Foundation, NutroPharma
- Study start
- Apr 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Treatment was given to the mothers assigned to the galactogogue group, whereas a placebo was given to those assigned to the placebo group. Each patient randomized to either treatment or placebo group received 28 sachets for 14 days of the trial.
| Arm | Type | Receives |
|---|---|---|
| Femaltiker | Experimental | Other: Femaltiker7.7 g of Femaltiker twice a day for 14 days of the trial. |
| placebo | Placebo comparator | Other: Placebo7.7 g placebo 14 days of the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mothers of preterm infants (born before 37 completed weeks of pregnancy)
Key exclusion criteria (3 listed)
- hypothyroidism
- diabetes type I or II diagnosed and treated before pregnancy
- participating in other study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FemaltikerAlso: LACTANELL formulaPatient had taken twice a day the product | Other | Femaltiker |
| PlaceboPatient had taken twice a day the placebo | Other | placebo |
Primary outcome
The volume of milk produced by study participants
Time frame: two weeks after delivery
Measurement of the volume of expressed milk
Level of serum prolactin
Time frame: two weeks after delivery
Three consecutive blood collections for prolactin level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Lactation Induced
RecruitingObservational study
Birth & Breastfeeding Support Study
Breastfeeding, Breastfeeding Initiation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandra Wesolowska, PhD study director
Warsaw Medical University, Department of Neonatology
Maria K. Borszewska-Kornacka, Prof. principal investigator
Warsaw Medical University Hospital, Department of Neonatology and Intensive Care Unit
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femaltiker in people with Lactation Induced, run by Medical University of Warsaw at 4 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The volume of milk produced by study participants (time frame: two weeks after delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.