Trial | NCT03577587  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    106
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.
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 Started
Aug 14
2017
Primary Completion
Feb 10
2022
Study Completion
Feb 10
2022
Last Update
May 03
2022

Dietary Supplement Silitidil for 21 days

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

  • Other names: Silitidil

Dietary Supplement Placebo for 21 days

daily ingestion of Placebo preparation over time period of 3 weeks

  • Other names: Placebo

Verum Experimental

Silitidil for 21 days

Placebo Placebo Comparator

Placebo for 21 days

Reference group No Intervention

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

Criteria 

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
No Results Posted