Efficacy of Herbal Galactagogue Silitidil After Preterm Birth

Breast Milk Production Clinical Trial

Official title:

Effect and Efficacy of the Herbal Galactagogue Silitidil From Milk Thistle in Mothers of Very Preterm Newborns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03577587
• Other study ID #: EWK-002
• Status: Completed
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: February 10, 2022

Study information

• Verified date: May 2022
• Source: Waldkrankenhaus Protestant Hospital, Spandau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 newborns is investigated.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Milk Production
• Human Milk Feeding
• Hypogalactia
• Lactation Disorders
• Premature Birth
• Preterm Infant Nutrition

Intervention

Dietary Supplement:
• Silitidil for 21 days
daily ingestion of herbal galactagogue Silitidil over time period of 3 weeks
• Placebo for 21 days
daily ingestion of Placebo preparation over time period of 3 weeks

Locations

Country	Name	City	State
Germany	Evangelic Waldkrankenhaus Spandau, Paul Gerhardt Diakonie	Berlin-Spandau

Sponsors (2)

Lead Sponsor	Collaborator
Waldkrankenhaus Protestant Hospital, Spandau	DMK Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Maternal alpha-Amylase level in saliva	Maternal alpha-amylase levels before and after breast pumping are determined in saliva samples	4 weeks
Other	Maternal cortisol level in saliva	Maternal cortisol levels before and after breast pumping are determined in saliva samples	4 weeks
Other	Incidence of mastitis	Incidence of clinical mastitis during intervention period	4 weeks
Primary	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	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
Secondary	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
Secondary	Milk Protein Content during intervention	Protein content in breast milk sample (mg/100ml)	at 1 week after study initiation
Secondary	Milk Protein Content at end of intervention	Protein content in breast milk sample (mg/100ml)	at 3 weeks after study initiation
Secondary	Milk Protein Content after intervention	Protein content in breast milk sample (mg/100ml)	at 4 weeks after study initiation
Secondary	Milk lactose Content during intervention	Lactose content in breast milk sample (mg/100ml)	at 1 week after study initiation
Secondary	Milk lactose Content at end of intervention	Lactose content in breast milk sample (mg/100ml)	at 3 weeks after study initiation
Secondary	Milk lactose Content after intervention	Lactose content in breast milk sample (mg/100ml)	at 4 weeks after study initiation
Secondary	Milk fatty acids Content during intervention	Fatty acids content in breast milk sample (mg/100ml)	at 1week after study initiation
Secondary	Milk fatty acids Content at end of intervention	Fatty acids content in breast milk sample (mg/100ml)	at 3 weeks after study initiation
Secondary	Milk fatty acids Content after intervention	Fatty acids content in breast milk sample (mg/100ml)	at 4 weeks after study initiation
Secondary	Incidence of formula feeding	Incidence of (additional) formula feeding at 4 weeks of life	4 weeks
Secondary	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
Secondary	Percentage of human milk feeding	Percentage of human milk feeding on total feeding volume of the preterm infant	4 weeks
Secondary	daily milk production (ml/24h), baseline	Daily milk production (ml/24h) according to pumping protocol	at 0, 1 and 2 weeks after study initiation
Secondary	daily milk production (ml/24h), follow-up	Daily milk production (ml/24h) according to pumping protocol	4 weeks after study initiation