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

Tel Aviv Sourasky Medical Center

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Preterms

Lactation

Treatments

Drug: Fenugreek seed meal

Study type

Interventional

Funder types

Other

Identifiers

NCT02384655

0652-14-TLV-RM

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Healthy mothers 7 to 14 days postpartum,
Mothers of preterm infants under 38 weeks of gestation,
Mothers with poor milk supply documented by professional lactation consultants.

Exclusion criteria

Mothers with mastitis,
Mothers with breast engorgement,
Mothers currently consuming Reglan, Domperidone or other drugs/herbals used to induce milk production,
Mothers who are taking medications (Diuretics, Pseudoephedrine, - Anticholinergics, Warfarin or any anticoagulant, An estrogen-containing birth control pill),
Mothers with Diabetes mellitus,
Mothers who have had breast surgery that could alter milk synthesis or production,
Mothers diagnosed with Polycystic Ovary Syndrome,
Mothers diagnosed with Asthma or atopic disease,
Mothers who are known to be allergic to peanuts or soybeans,
Mothers whose milk supply per 24 hours exceeds 600 mL,
Mothers with hypo/hyperthyroidism