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

June 15, 2020 updated by: Tel-Aviv Sourasky Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Department of Neonatology Tel Aviv Medical Center
        • Contact:
          • Ronella Marom, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fenugreek
Mothers will take fenugreek for 14 days
Drug: Fenugreek seed meal
3x3 capsules of fenugreek seeds per day for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in daily volume of expressed milk
Time Frame: at day 0, 3, 7, 10, 14
at day 0, 3, 7, 10, 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Macronutrient content analysis of breastmilk
Time Frame: at day 0, 3, 7, 14
at day 0, 3, 7, 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Ronella Marom, MD, Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2015

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Actual)

June 17, 2020

Last Update Submitted That Met QC Criteria

June 15, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0652-14-TLV-RM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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