Effect of Fenugreek Use in Mothers of Preterm on Breast Milk Production and Macronutrient Content
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02384655|
Recruitment Status : Recruiting
First Posted : March 10, 2015
Last Update Posted : June 17, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Preterms Lactation||Drug: Fenugreek seed meal||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Fenugreek Use in Mothers of Preterm on Breast Milk Production and Macronutrient Content|
|Actual Study Start Date :||March 11, 2015|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||September 2021|
Mothers will take fenugreek for 14 days
Drug: Fenugreek seed meal
3x3 capsules of fenugreek seeds per day for 14 days
- Change in daily volume of expressed milk [ Time Frame: at day 0, 3, 7, 10, 14 ]
- Change in Macronutrient content analysis of breastmilk [ Time Frame: at day 0, 3, 7, 14 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384655
|Contact: Ronella Marom, MDemail@example.com|
|Department of Neonatology Tel Aviv Medical Center||Recruiting|
|Tel Aviv, Israel, 64239|
|Contact: Ronella Marom, MD|
|Principal Investigator:||Ronella Marom, MD||Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center|