Efficacy of Herbal Galactagogue Silitidil After Preterm Birth

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Milk Production, Human Milk Feeding, Hypogalactia, Preterm Infant Nutrition

Intervention / Treatment
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* Dietary Supplement: Silitidil for 21 days
* Dietary Supplement: Placebo for 21 days


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum<br>Silitidil for 21 days | Dietary Supplement: Silitidil for 21 days<br>* daily ingestion of herbal galactagogue Silitidil over time period of 3 weeks<br>* Other names: Silitidil;|
| Placebo Comparator: Placebo<br>Placebo for 21 days | Dietary Supplement: Placebo for 21 days<br>* daily ingestion of Placebo preparation over time period of 3 weeks<br>* Other names: Placebo;|
| No Intervention: Reference group<br>Non-randomized healthy volunteering mothers after term birth receiving no intervention | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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galactagogue, milk thistle, silymarin, Silitidil