Efficacy of Herbal Galactagogue Silitidil After Preterm Birth

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
• Conditions: Breast Milk Production; Human Milk Feeding; Hypogalactia; Preterm Infant Nutrition
• Intervention / Treatment: Dietary supplement: Silitidil for 21 days; Dietary supplement: Placebo for 21 days

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

Study Locations

• Germany
  • Berlin-Spandau, Germany, 13589
    • Evangelic Waldkrankenhaus Spandau, Paul Gerhardt Diakonie

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentual increase in daily milk production	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	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	Protein content in breast milk sample (mg/100ml)	at 1 week after study initiation
Milk Protein Content at end of intervention	Protein content in breast milk sample (mg/100ml)	at 3 weeks after study initiation
Milk Protein Content after intervention	Protein content in breast milk sample (mg/100ml)	at 4 weeks after study initiation
Milk lactose Content during intervention	Lactose content in breast milk sample (mg/100ml)	at 1 week after study initiation
Milk lactose Content at end of intervention	Lactose content in breast milk sample (mg/100ml)	at 3 weeks after study initiation
Milk lactose Content after intervention	Lactose content in breast milk sample (mg/100ml)	at 4 weeks after study initiation
Milk fatty acids Content during intervention	Fatty acids content in breast milk sample (mg/100ml)	at 1week after study initiation
Milk fatty acids Content at end of intervention	Fatty acids content in breast milk sample (mg/100ml)	at 3 weeks after study initiation
Milk fatty acids Content after intervention	Fatty acids content in breast milk sample (mg/100ml)	at 4 weeks after study initiation
Incidence of formula feeding	Incidence of (additional) formula feeding at 4 weeks of life	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	4 weeks
Percentage of human milk feeding	Percentage of human milk feeding on total feeding volume of the preterm infant	4 weeks
daily milk production (ml/24h), baseline	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	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	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	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	Maternal alpha-amylase levels before and after breast pumping are determined in saliva samples	4 weeks
Maternal cortisol level in saliva	Maternal cortisol levels before and after breast pumping are determined in saliva samples	4 weeks
Incidence of mastitis	Incidence of clinical mastitis during intervention period	4 weeks

Collaborators and Investigators

• Sponsor: Waldkrankenhaus Protestant Hospital, Spandau
• Collaborators: DMK Group
• Investigators: Study Director: Frank Jochum, MD, Head of Paediatric Department

Study record dates

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: silymarin; galactagogue; milk thistle; Silitidil
• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Obstetric Labor, Premature; Premature Birth; Lactation Disorders
• 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