Effect of Fenugreek Use in Mothers of Preterm on Breast M... | NCT02384655

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

NCT02384655

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Jun 17, 2020Actual

Enrollment

30Estimated

Phase

Phase 1Phase 2

Conditions

Preterms
Lactation

Interventions

Fenugreek seed meal

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2015Actual

Primary Completion Date

Jun 2021Estimated

Completion Date

Sep 2021Estimated

First Submitted Date

Feb 24, 2015

First Submission Date that Met QC Criteria

Mar 4, 2015

First Posted Date

Mar 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2020

Last Update Posted Date

Jun 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fenugreek	Experimental	Mothers will take fenugreek for 14 days	Drug: Fenugreek seed meal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fenugreek seed meal	Drug	3x3 capsules of fenugreek seeds per day for 14 days	Fenugreek

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ronella Marom, MD	Contact	+97236925690		ronellam@tlvmc.gov.il

Overall Officials

Name	Affiliation	Role
Ronella Marom, MD	Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neonatology Tel Aviv Medical Center	Recruiting	Tel Aviv		64239	Israel

ID	Term
D001942	Breast Feeding

ID	Term
D005247	Feeding Behavior
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
C056164	fenugreek seed meal

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided