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

Lactation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02384655
• Other study ID #: 0652-14-TLV-RM
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 11, 2015
• Est. completion date: September 2021

Study information

• Verified date: June 2020
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Ronella Marom, MD
• Phone: +97236925690
• Email: ronellam[@]tlvmc.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lactation
• Premature Birth
• Preterms

Intervention

Drug:
• Fenugreek seed meal
3x3 capsules of fenugreek seeds per day for 14 days

Locations

Country	Name	City	State
Israel	Department of Neonatology Tel Aviv Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in daily volume of expressed milk		at day 0, 3, 7, 10, 14
Secondary	Change in Macronutrient content analysis of breastmilk		at day 0, 3, 7, 14