NCT03577587

Brief 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 newborns is investigated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
Last Updated

May 3, 2022

Status Verified

May 1, 2022

Enrollment Period

4.5 years

First QC Date

January 9, 2018

Last Update Submit

May 1, 2022

Conditions

Breast Milk ProductionHuman Milk FeedingHypogalactiaPreterm Infant Nutrition

Keywords

galactagoguemilk thistlesilymarinSilitidil

Outcome Measures

Primary Outcomes (1)

  • Daily milk production (ml/24h) at end of Intervention period

    Daily milk production (ml/24h) according to pumping protocol

    3 weeks after study initiation

Secondary Outcomes (16)

  • Percentual increase in daily milk production

    from 0 to 3 weeks after study initiation

  • Percentual increase in daily milk production

    from 0 to 4 weeks after study initiation

  • Milk Protein Content during intervention

    at 1 week after study initiation

  • Milk Protein Content at end of intervention

    at 3 weeks after study initiation

  • Milk Protein Content after intervention

    at 4 weeks after study initiation

  • +11 more secondary outcomes

Other Outcomes (5)

  • Maternal urine oxytocin/creatinin-ratio

    4 weeks

  • Maternal Urine prolactin/creatinin-ratio

    4 weeks

  • Maternal alpha-Amylase level in saliva

    4 weeks

  • +2 more other outcomes

Study Arms (3)

Verum

EXPERIMENTAL

Silitidil for 21 days

Dietary Supplement: Silitidil for 21 days

Placebo

PLACEBO COMPARATOR

Placebo for 21 days

Dietary Supplement: Placebo for 21 days

Reference group

NO INTERVENTION

Non-randomized healthy volunteering mothers after term birth receiving no intervention

Interventions

Silitidil for 21 daysDIETARY_SUPPLEMENT

daily ingestion of herbal galactagogue Silitidil over time period of 3 weeks

Also known as: Silitidil
Verum
Placebo for 21 daysDIETARY_SUPPLEMENT

daily ingestion of Placebo preparation over time period of 3 weeks

Also known as: Placebo
Placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • mothers after preterm birth \<= 32 weeks of gestation
  • Age of the newborn 1 - 5 days
  • Human milk feeding intended

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evangelic Waldkrankenhaus Spandau, Paul Gerhardt Diakonie

Berlin-Spandau, 13589, Germany

Location

MeSH Terms

Conditions

Lactation Disorders

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Frank Jochum, MD

    Head of Paediatric Department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Institute for Pediatric Nutritional Research at the Waldkrankenhaus Protestant Hospital

Study Record Dates

First Submitted

January 9, 2018

First Posted

July 5, 2018

Study Start

August 14, 2017

Primary Completion

February 10, 2022

Study Completion

February 10, 2022

Last Updated

May 3, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)