- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03577587
Efficacy of Herbal Galactagogue Silitidil After Preterm Birth
May 1, 2022 updated by: Dr. Hanna Petersen, Waldkrankenhaus Protestant Hospital, Spandau
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
106
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin-Spandau, Germany, 13589
- Evangelic Waldkrankenhaus Spandau, Paul Gerhardt Diakonie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- mothers after preterm birth <= 32 weeks of gestation
- Age of the newborn 1 - 5 days
- Human milk feeding intended
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Verum
Silitidil for 21 days
|
daily ingestion of herbal galactagogue Silitidil over time period of 3 weeks
Other Names:
|
Placebo Comparator: Placebo
Placebo for 21 days
|
daily ingestion of Placebo preparation over time period of 3 weeks
Other Names:
|
No Intervention: Reference group
Non-randomized healthy volunteering mothers after term birth receiving no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 weeks after study initiation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentual increase in daily milk production
Time Frame: from 0 to 3 weeks after study initiation
|
Percentual increase in daily milk production comparing daily milk production (ml/24h) before and at end of intervention
|
from 0 to 3 weeks after study initiation
|
Percentual increase in daily milk production
Time Frame: from 0 to 4 weeks after study initiation
|
Percentual increase in daily milk production comparing daily milk production (ml/24h) before and 1 week after intervention
|
from 0 to 4 weeks after study initiation
|
Milk Protein Content during intervention
Time Frame: at 1 week after study initiation
|
Protein content in breast milk sample (mg/100ml)
|
at 1 week after study initiation
|
Milk Protein Content at end of intervention
Time Frame: at 3 weeks after study initiation
|
Protein content in breast milk sample (mg/100ml)
|
at 3 weeks after study initiation
|
Milk Protein Content after intervention
Time Frame: at 4 weeks after study initiation
|
Protein content in breast milk sample (mg/100ml)
|
at 4 weeks after study initiation
|
Milk lactose Content during intervention
Time Frame: at 1 week after study initiation
|
Lactose content in breast milk sample (mg/100ml)
|
at 1 week after study initiation
|
Milk lactose Content at end of intervention
Time Frame: at 3 weeks after study initiation
|
Lactose content in breast milk sample (mg/100ml)
|
at 3 weeks after study initiation
|
Milk lactose Content after intervention
Time Frame: at 4 weeks after study initiation
|
Lactose content in breast milk sample (mg/100ml)
|
at 4 weeks after study initiation
|
Milk fatty acids Content during intervention
Time Frame: at 1week after study initiation
|
Fatty acids content in breast milk sample (mg/100ml)
|
at 1week after study initiation
|
Milk fatty acids Content at end of intervention
Time Frame: at 3 weeks after study initiation
|
Fatty acids content in breast milk sample (mg/100ml)
|
at 3 weeks after study initiation
|
Milk fatty acids Content after intervention
Time Frame: at 4 weeks after study initiation
|
Fatty acids content in breast milk sample (mg/100ml)
|
at 4 weeks after study initiation
|
Incidence of formula feeding
Time Frame: 4 weeks
|
Incidence of (additional) formula feeding at 4 weeks of life
|
4 weeks
|
Time point when enteral feeding volumes reach 120 ml/kgbw
Time Frame: 4 weeks
|
day of life when enteral feeding volumes of the preterm Infant have reached 120 ml per kg bodyweight
|
4 weeks
|
Percentage of human milk feeding
Time Frame: 4 weeks
|
Percentage of human milk feeding on total feeding volume of the preterm infant
|
4 weeks
|
daily milk production (ml/24h), baseline
Time Frame: at 0, 1 and 2 weeks after study initiation
|
Daily milk production (ml/24h) according to pumping protocol
|
at 0, 1 and 2 weeks after study initiation
|
daily milk production (ml/24h), follow-up
Time Frame: 4 weeks after study initiation
|
Daily milk production (ml/24h) according to pumping protocol
|
4 weeks after study initiation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal urine oxytocin/creatinin-ratio
Time Frame: 4 weeks
|
Maternal urine oxytocin and creatinin levels before and after breast pumping are determined to create oxytocin/creatin-ratio
|
4 weeks
|
Maternal Urine prolactin/creatinin-ratio
Time Frame: 4 weeks
|
Maternal urine prolactin and creatinin levels before and after breast pumping are determined to create prolactin/creatin-ratio
|
4 weeks
|
Maternal alpha-Amylase level in saliva
Time Frame: 4 weeks
|
Maternal alpha-amylase levels before and after breast pumping are determined in saliva samples
|
4 weeks
|
Maternal cortisol level in saliva
Time Frame: 4 weeks
|
Maternal cortisol levels before and after breast pumping are determined in saliva samples
|
4 weeks
|
Incidence of mastitis
Time Frame: 4 weeks
|
Incidence of clinical mastitis during intervention period
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Frank Jochum, MD, Head of Paediatric Department
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 14, 2017
Primary Completion (Actual)
February 10, 2022
Study Completion (Actual)
February 10, 2022
Study Registration Dates
First Submitted
January 9, 2018
First Submitted That Met QC Criteria
July 3, 2018
First Posted (Actual)
July 5, 2018
Study Record Updates
Last Update Posted (Actual)
May 3, 2022
Last Update Submitted That Met QC Criteria
May 1, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EWK-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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