NCT02384655

Effect of Fenugreek Use in Mothers of Preterm on Breast Milk Production and Macronutrient Content

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Feeding human milk to preterm infants does reduce the risk of serious and costly neonatal intensive care unit acquired morbidity such as NEC and the late onset sepsis. It is often difficult to obtain sufficient quantities of human milk from mothers of preterm infants most of whom are breast pump-dependent for weeks or months. Mothers will try to use galactogogues in an attempt to increase milk production. Fenugreek (Trigonella foenum-graecum) seeds is the most commonly used herbal galactogogue and is a member of the pea family. Our experience at the NICU is that around 30% of preterm mothers desperately looking for ways to increase their breast milk supply will eventually took fenugreek (Hilbe) as food supplement. Although widely recommended, there is limited evidence to support the effectiveness of fenugreek as a galactogogue. The aims of this study are to evaluate whether maternal consumption of fenugreek seeds has any effect on macronutrients composition of breast milk and whether fenugreek is transferred to the infant via mother milk. In addition any changes in mother and infant health status will be assessed.

Conditions

• Preterms
• Lactation

Interventions

Type	Name	Description
DRUG	Fenugreek seed meal	3x3 capsules of fenugreek seeds per day for 14 days

Timeline

• Start date: 2015-03-11
• Primary completion: 2021-06-01
• Completion: 2021-09-01
• First posted: 2015-03-10
• Last updated: 2020-06-17

Locations

1 site across 1 country: Israel