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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Germany
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Verum
Silitidil for 21 days
Dietary supplement: Silitidil for 21 days
daily ingestion of herbal galactagogue Silitidil over time period of 3 weeks
Other Names:
  • Silitidil
Placebo Comparator: Placebo
Placebo for 21 days
Dietary supplement: Placebo for 21 days
daily ingestion of Placebo preparation over time period of 3 weeks
Other Names:
  • Placebo
No Intervention: Reference group
Non-randomized healthy volunteering mothers after term birth receiving no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Waldkrankenhaus Protestant Hospital, Spandau

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
DMK Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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