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

Phase 1

• Conditions: Preterms; Lactation
• Interventions: Drug: Fenugreek seed meal

• Registration Number: NCT02384655
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-10
• Study Start: 2015-03-11
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-15
• Last Update Posted: 2020-06-17
• Primary Completion: 2021-06
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fenugreek	Fenugreek seed meal	Mothers will take fenugreek for 14 days

Primary Outcome Measures

Name	Time	Method
Change in daily volume of expressed milk	at day 0, 3, 7, 10, 14

Secondary Outcome Measures

Name	Time	Method
Change in Macronutrient content analysis of breastmilk	at day 0, 3, 7, 14

Trial Locations

Locations (1)

Department of Neonatology Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel