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

Primary Purpose

Preterms, Lactation

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Fenugreek seed meal
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterms focused on measuring Preterms, Breastfeeding, Lactation, Macronutrients

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Department of Neonatology Tel Aviv Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fenugreek

Arm Description

Mothers will take fenugreek for 14 days

Outcomes

Primary Outcome Measures

Change in daily volume of expressed milk

Secondary Outcome Measures

Change in Macronutrient content analysis of breastmilk

Full Information

First Posted
February 24, 2015
Last Updated
June 15, 2020
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02384655
Brief Title
Effect of Fenugreek Use in Mothers of Preterm on Breast Milk Production and Macronutrient Content
Official Title
Effect of Fenugreek Use in Mothers of Preterm on Breast Milk Production and Macronutrient Content
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 11, 2015 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterms, Lactation
Keywords
Preterms, Breastfeeding, Lactation, Macronutrients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fenugreek
Arm Type
Experimental
Arm Description
Mothers will take fenugreek for 14 days
Intervention Type
Drug
Intervention Name(s)
Fenugreek seed meal
Intervention Description
3x3 capsules of fenugreek seeds per day for 14 days
Primary Outcome Measure Information:
Title
Change in daily volume of expressed milk
Time Frame
at day 0, 3, 7, 10, 14
Secondary Outcome Measure Information:
Title
Change in Macronutrient content analysis of breastmilk
Time Frame
at day 0, 3, 7, 14

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronella Marom, MD
Phone
+97236925690
Email
ronellam@tlvmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronella Marom, MD
Organizational Affiliation
Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neonatology Tel Aviv Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronella Marom, MD

12. IPD Sharing Statement

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

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