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Efficacy of Herbal Galactagogue Silitidil After Preterm Birth

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ClinicalTrials.gov Identifier: NCT03577587
Recruitment Status : Recruiting
First Posted : July 4, 2018
Last Update Posted : July 4, 2018
Sponsor:
Collaborator:
DMK Group
Information provided by (Responsible Party):
Dr. Hanna Petersen, Waldkrankenhaus Protestant Hospital, Spandau

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Milk Production Human Milk Feeding Hypogalactia Preterm Infant Nutrition Dietary Supplement: Silitidil for 21 days Dietary Supplement: Placebo for 21 days Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect and Efficacy of the Herbal Galactagogue Silitidil From Milk Thistle in Mothers of Very Preterm Newborns
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

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 Name: 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 Name: Placebo

No Intervention: Reference group
Non-randomized healthy volunteering mothers after term birth receiving no intervention



Primary Outcome Measures :
  1. Daily milk production (ml/24h) at end of Intervention period [ Time Frame: 3 weeks after study initiation ]
    Daily milk production (ml/24h) according to pumping protocol


Secondary Outcome Measures :
  1. Percentual increase in daily milk production [ Time Frame: from 0 to 3 weeks after study initiation ]
    Percentual increase in daily milk production comparing daily milk production (ml/24h) before and at end of intervention

  2. Percentual increase in daily milk production [ Time Frame: from 0 to 4 weeks after study initiation ]
    Percentual increase in daily milk production comparing daily milk production (ml/24h) before and 1 week after intervention

  3. Milk Protein Content during intervention [ Time Frame: at 1 week after study initiation ]
    Protein content in breast milk sample (mg/100ml)

  4. Milk Protein Content at end of intervention [ Time Frame: at 3 weeks after study initiation ]
    Protein content in breast milk sample (mg/100ml)

  5. Milk Protein Content after intervention [ Time Frame: at 4 weeks after study initiation ]
    Protein content in breast milk sample (mg/100ml)

  6. Milk lactose Content during intervention [ Time Frame: at 1 week after study initiation ]
    Lactose content in breast milk sample (mg/100ml)

  7. Milk lactose Content at end of intervention [ Time Frame: at 3 weeks after study initiation ]
    Lactose content in breast milk sample (mg/100ml)

  8. Milk lactose Content after intervention [ Time Frame: at 4 weeks after study initiation ]
    Lactose content in breast milk sample (mg/100ml)

  9. Milk fatty acids Content during intervention [ Time Frame: at 1week after study initiation ]
    Fatty acids content in breast milk sample (mg/100ml)

  10. Milk fatty acids Content at end of intervention [ Time Frame: at 3 weeks after study initiation ]
    Fatty acids content in breast milk sample (mg/100ml)

  11. Milk fatty acids Content after intervention [ Time Frame: at 4 weeks after study initiation ]
    Fatty acids content in breast milk sample (mg/100ml)

  12. Incidence of formula feeding [ Time Frame: 4 weeks ]
    Incidence of (additional) formula feeding at 4 weeks of life

  13. Time point when enteral feeding volumes reach 120 ml/kgbw [ Time Frame: 4 weeks ]
    day of life when enteral feeding volumes of the preterm Infant have reached 120 ml per kg bodyweight

  14. Percentage of human milk feeding [ Time Frame: 4 weeks ]
    Percentage of human milk feeding on total feeding volume of the preterm infant

  15. daily milk production (ml/24h), baseline [ Time Frame: at 0, 1 and 2 weeks after study initiation ]
    Daily milk production (ml/24h) according to pumping protocol

  16. daily milk production (ml/24h), follow-up [ Time Frame: 4 weeks after study initiation ]
    Daily milk production (ml/24h) according to pumping protocol


Other Outcome Measures:
  1. Maternal urine oxytocin/creatinin-ratio [ Time Frame: 4 weeks ]
    Maternal urine oxytocin and creatinin levels before and after breast pumping are determined to create oxytocin/creatin-ratio

  2. Maternal Urine prolactin/creatinin-ratio [ Time Frame: 4 weeks ]
    Maternal urine prolactin and creatinin levels before and after breast pumping are determined to create prolactin/creatin-ratio

  3. Maternal alpha-Amylase level in saliva [ Time Frame: 4 weeks ]
    Maternal alpha-amylase levels before and after breast pumping are determined in saliva samples

  4. Maternal cortisol level in saliva [ Time Frame: 4 weeks ]
    Maternal cortisol levels before and after breast pumping are determined in saliva samples

  5. Incidence of mastitis [ Time Frame: 4 weeks ]
    Incidence of clinical mastitis during intervention period



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577587


Contacts
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Contact: Antonia Nomayo, MD 0049 30 3702 ext 2025 antonia.nomayo@pgdiakonie.de
Contact: Frank Jochum, MD 0049 30 3702 ext 1022 frank.jochum@pgdiakonie.de

Locations
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Germany
Evangelic Waldkrankenhaus Spandau, Paul Gerhardt Diakonie Recruiting
Berlin-Spandau, Germany, 13589
Contact: Antonia Nomayo, MD    0049 30 3702 ext 2025    antonia.nomayo@pgdiakonie.de   
Contact: Frank Jochum, MD    0049 30 3702 ext 1022    frank.jochum@pgdiakonie.de   
Sub-Investigator: Antonia Nomayo, MD         
Sub-Investigator: Hanna Petersen, MD         
Sub-Investigator: Titus Sabi, MD         
Sponsors and Collaborators
Waldkrankenhaus Protestant Hospital, Spandau
DMK Group
Investigators
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Study Director: Frank Jochum, MD Head of Paediatric Department

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Responsible Party: Dr. Hanna Petersen, Head of Institute for Pediatric Nutritional Research at the Waldkrankenhaus Protestant Hospital, Waldkrankenhaus Protestant Hospital, Spandau
ClinicalTrials.gov Identifier: NCT03577587     History of Changes
Other Study ID Numbers: EWK-002
First Posted: July 4, 2018    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Hanna Petersen, Waldkrankenhaus Protestant Hospital, Spandau:
galactagogue
milk thistle
silymarin
Silitidil
Additional relevant MeSH terms:
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Premature Birth
Lactation Disorders
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Breast Diseases
Skin Diseases
Galactogogues
Physiological Effects of Drugs