Breast Milk ProductionNCT03577587
Efficacy of Herbal Galactagogue Silitidil After Preterm Birth
A study testing Silitidil for 21 days in people with Breast Milk Production and Human Milk Feeding, run by Waldkrankenhaus Protestant Hospital, Spandau at 1 site in Germany.
Trial summary
After preterm birth mothers often suffer from hypogalactia. Herbal galactogogues can be used in order to increase milk production. In this double-blind, randomized, placebo-controlled clinical trial the effect of Silitidil, an extract from milk thistle, on the postpartal milk production in mothers of very premature… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Milk Production, Human Milk Feeding, Hypogalactia
- What is being tested?
- Silitidil for 21 days
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteGermany
- Study dates
- 14 Aug 2017to 10 Feb 2022
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- mothers after preterm birth <= 32 weeks of gestation
- Age of the newborn 1 - 5 days
- Human milk feeding intended
Who cannot join
- Ingestion of other galactagogues
- maternal chronical disease requiring therapy (e.g. severe hypothyreosis, preexistent arterial hypertension, Type I or 2 Diabetes, chronic inflammatory bowel disease, severe bronchial asthma, pollinosis)
- medication influencing prolactine levels
- Mastitis at time of enrollment
- mammary tumors or surgery influencing milk production
Trial locations and contacts
1 site in 1 country.
Germany1 site
Evangelic Waldkrankenhaus Spandau, Paul Gerhardt Diakonie
Berlin-Spandau, 13589
About this study
Official title: Effect and Efficacy of the Herbal Galactagogue Silitidil From Milk Thistle in Mothers of Very Preterm Newborns
After preterm birth mothers often suffer from hypogalactia. Herbal galactogogues can be used in order to increase milk production. In this double-blind, randomized, placebo-controlled clinical trial the effect of Silitidil, an extract from milk thistle, on the postpartal milk production in mothers of very premature newborns is investigated.
Read the detailed description
Mothers of preterm infants born at a gestational age <= 32 wg are asked to participate in this double-blind, randomized, placebo-controlled interventional trial, where they will receive a preparation of the herbal galactogogue Silitidil or placebo over an intervention period of 3 weeks. The influence of the galactagogue will be investigated by monitoring daily milk production before, during and 1 week after cessation of the intervention. As secondary outcome parameters weight gain, the progress of enteral feeding, and the percentage of human milk feeding on total enteral feeding volumes will be monitored in the newborn infants. Also the breast milk composition (in terms of fatty acids, protein and carbohydrates content) will be investigated and compared between study groups. Saliva and urine probes will be collected at specific time points to survey hormonal reactions during the various phases of lactation and the relation of maternal hormone levels on milk production.
- Being tested
- Silitidil for 21 days, Placebo for 21 days
- Keywords
- galactagogue, milk thistle, silymarin, Silitidil
- Medical subject headings
- Lactation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silitidil for 21 daysDietary supplement
Also called Silitidil
daily ingestion of herbal galactagogue Silitidil over time period of 3 weeks
Placebo for 21 daysDietary supplement
Also called Placebo
daily ingestion of Placebo preparation over time period of 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Silitidil for 21 days Receives: Dietary Supplement: Silitidil for 21 days |
| Placebo | Placebo comparator | Placebo for 21 days Receives: Dietary Supplement: Placebo for 21 days |
| Reference group | No intervention | Non-randomized healthy volunteering mothers after term birth receiving no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily milk production (ml/24h) at end of Intervention period
Daily milk production (ml/24h) according to pumping protocol
Measured: 3 weeks after study initiation
Secondary outcomes (16)
Percentual increase in daily milk production
Percentual increase in daily milk production comparing daily milk production (ml/24h) before and at end of intervention
Measured: from 0 to 3 weeks after study initiation
Percentual increase in daily milk production
Percentual increase in daily milk production comparing daily milk production (ml/24h) before and 1 week after intervention
Measured: from 0 to 4 weeks after study initiation
Milk Protein Content during intervention
Protein content in breast milk sample (mg/100ml)
Measured: at 1 week after study initiation
Milk Protein Content at end of intervention
Protein content in breast milk sample (mg/100ml)
Measured: at 3 weeks after study initiation
Milk Protein Content after intervention
Protein content in breast milk sample (mg/100ml)
Measured: at 4 weeks after study initiation
Milk lactose Content during intervention
Lactose content in breast milk sample (mg/100ml)
Measured: at 1 week after study initiation
Milk lactose Content at end of intervention
Lactose content in breast milk sample (mg/100ml)
Measured: at 3 weeks after study initiation
Milk lactose Content after intervention
Lactose content in breast milk sample (mg/100ml)
Measured: at 4 weeks after study initiation
Milk fatty acids Content during intervention
Fatty acids content in breast milk sample (mg/100ml)
Measured: at 1week after study initiation
Milk fatty acids Content at end of intervention
Fatty acids content in breast milk sample (mg/100ml)
Measured: at 3 weeks after study initiation
Milk fatty acids Content after intervention
Fatty acids content in breast milk sample (mg/100ml)
Measured: at 4 weeks after study initiation
Incidence of formula feeding
Incidence of (additional) formula feeding at 4 weeks of life
Measured: 4 weeks
Time point when enteral feeding volumes reach 120 ml/kgbw
day of life when enteral feeding volumes of the preterm Infant have reached 120 ml per kg bodyweight
Measured: 4 weeks
Percentage of human milk feeding
Percentage of human milk feeding on total feeding volume of the preterm infant
Measured: 4 weeks
daily milk production (ml/24h), baseline
Daily milk production (ml/24h) according to pumping protocol
Measured: at 0, 1 and 2 weeks after study initiation
daily milk production (ml/24h), follow-up
Daily milk production (ml/24h) according to pumping protocol
Measured: 4 weeks after study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start14 Aug 2017
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Milk ProductionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Waldkrankenhaus Protestant Hospital, Spandau
- Sponsor type
- University, hospital or other
- Collaborators
- DMK Group
- Responsible party
- Principal investigator, Dr. Hanna Petersen, Waldkrankenhaus Protestant Hospital, Spandau
- Investigators
- Frank Jochum, MD, Study director, Head of Paediatric Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577587
- Sponsor's protocol ID
- EWK-002
- Status last verified
- May 2022
- First submitted
- 9 Jan 2018
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Efficacy of the Herbal Galactagogue Silitidil From Milk Thistle in Mothers of Very Preterm Newborns
- ClinicalTrials.gov ID
- NCT03577587
- Acronym / sponsor ID
- EWK-002
- Keywords
- galactagogue, milk thistle, silymarin, Silitidil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Waldkrankenhaus Protestant Hospital, SpandauUniversity, hospital or other
- Collaborators
- DMK Group
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 5 Jul 2018 (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.
After preterm birth mothers often suffer from hypogalactia. Herbal galactogogues can be used in order to increase milk production. In this double-blind, randomized, placebo-controlled clinical trial the effect of Silitidil, an extract from milk thistle, on the postpartal milk production in mothers of very premature newborns is investigated.
Detailed description
Mothers of preterm infants born at a gestational age <= 32 wg are asked to participate in this double-blind, randomized, placebo-controlled interventional trial, where they will receive a preparation of the herbal galactogogue Silitidil or placebo over an intervention period of 3 weeks. The influence of the galactagogue will be investigated by monitoring daily milk production before, during and 1 week after cessation of the intervention. As secondary outcome parameters weight gain, the progress of enteral feeding, and the percentage of human milk feeding on total enteral feeding volumes will be monitored in the newborn infants. Also the breast milk composition (in terms of fatty acids, protein and carbohydrates content) will be investigated and compared between study groups. Saliva and urine probes will be collected at specific time points to survey hormonal reactions during the various phases of lactation and the relation of maternal hormone levels on milk production.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Dietary Supplement: Silitidil for 21 daysSilitidil for 21 days |
| Placebo | Placebo comparator | Dietary Supplement: Placebo for 21 daysPlacebo for 21 days |
| Reference group | No intervention | –Non-randomized healthy volunteering mothers after term birth receiving no intervention |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- mothers after preterm birth <= 32 weeks of gestation
- Age of the newborn 1 - 5 days
- Human milk feeding intended
Key exclusion criteria (5 listed)
- Ingestion of other galactagogues
- maternal chronical disease requiring therapy (e.g. severe hypothyreosis, preexistent arterial hypertension, Type I or 2 Diabetes, chronic inflammatory bowel disease, severe bronchial asthma, pollinosis)
- medication influencing prolactine levels
- Mastitis at time of enrollment
- mammary tumors or surgery influencing milk production
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 |
|---|---|---|
| Silitidil for 21 daysAlso: Silitidildaily ingestion of herbal galactagogue Silitidil over time period of 3 weeks | Dietary supplement | Verum |
| Placebo for 21 daysAlso: Placebodaily ingestion of Placebo preparation over time period of 3 weeks | Dietary supplement | Placebo |
Primary outcome
Daily milk production (ml/24h) at end of Intervention period
Time frame: 3 weeks after study initiation
Daily milk production (ml/24h) according to pumping protocol
16 secondary outcomes
Percentual increase in daily milk production
Time frame: from 0 to 3 weeks after study initiation
Percentual increase in daily milk production
Time frame: from 0 to 4 weeks after study initiation
Milk Protein Content during intervention
Time frame: at 1 week after study initiation
Milk Protein Content at end of intervention
Time frame: at 3 weeks after study initiation
Milk Protein Content after intervention
Time frame: at 4 weeks after study initiation
Milk lactose Content during intervention
Time frame: at 1 week after study initiation
Milk lactose Content at end of intervention
Time frame: at 3 weeks after study initiation
Milk lactose Content after intervention
Time frame: at 4 weeks after study initiation
Milk fatty acids Content during intervention
Time frame: at 1week after study initiation
Milk fatty acids Content at end of intervention
Time frame: at 3 weeks after study initiation
Milk fatty acids Content after intervention
Time frame: at 4 weeks after study initiation
Incidence of formula feeding
Time frame: 4 weeks
Time point when enteral feeding volumes reach 120 ml/kgbw
Time frame: 4 weeks
Percentage of human milk feeding
Time frame: 4 weeks
daily milk production (ml/24h), baseline
Time frame: at 0, 1 and 2 weeks after study initiation
daily milk production (ml/24h), follow-up
Time frame: 4 weeks after study initiation
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 3 May 2022.
- Individual participant dataSharing planned: No
Related trials for Breast Milk Production
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
RecruitingPhase 1
A Study to Evaluate Gepotidacin Exposure in Breast Milk of Healthy Lactating Women
Urinary Tract Infections
RecruitingPhase 1
A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women
Healthy
RecruitingPhase 4
Evaluation of the Excretion of Fosfomycin Into Breast Milk Following a Single Intravenous Dose of ZTI-01 (6 g) in Healthy Lactating Women
Healthy Lactating Women
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.
Frank Jochum, MD study director
Head of Paediatric Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silitidil for 21 days in people with Breast Milk Production and Human Milk Feeding, run by Waldkrankenhaus Protestant Hospital, Spandau at 1 site in Germany.
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 3 inclusion and 5 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 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Daily milk production (ml/24h) at end of Intervention period (time frame: 3 weeks after study initiation). 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 3 May 2022.