NCT03577587

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Waldkrankenhaus Protestant Hospital, Spandau · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

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.

Conditions

• Breast Milk Production
• Human Milk Feeding
• Hypogalactia
• Preterm Infant Nutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Silitidil for 21 days	daily ingestion of herbal galactagogue Silitidil over time period of 3 weeks
DIETARY_SUPPLEMENT	Placebo for 21 days	daily ingestion of Placebo preparation over time period of 3 weeks

Timeline

• Start date: 2017-08-14
• Primary completion: 2022-02-10
• Completion: 2022-02-10
• First posted: 2018-07-05
• Last updated: 2022-05-03

Locations

1 site across 1 country: Germany