PretermsPhase 1/2NCT02384655
Effect of Fenugreek Use in Mothers of Preterm on Breast Milk Production and Macronutrient Content
A Phase 1/2 study testing Fenugreek seed meal in people with Preterms and Lactation, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- What is being tested?
- Fenugreek seed meal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Mar 2015to Sep 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Neonatology Tel Aviv Medical Center
Tel Aviv, 64239
Ronella Marom, MD
About this study
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.
- Being tested
- Fenugreek seed meal
- Keywords
- Preterms, Breastfeeding, Lactation, Macronutrients
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenugreek seed mealDrug
3x3 capsules of fenugreek seeds per day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Fenugreek | Experimental | Mothers will take fenugreek for 14 days Receives: Drug: Fenugreek seed meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily volume of expressed milk
Measured: at day 0, 3, 7, 10, 14
Secondary outcomes (1)
Change in Macronutrient content analysis of breastmilk
Measured: at day 0, 3, 7, 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study start11 Mar 2015
- Primary completionJun 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermsStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ronella Marom, MD, Principal investigator, Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384655
- Sponsor's protocol ID
- 0652-14-TLV-RM
- Status last verified
- Jun 2020
- First submitted
- 24 Feb 2015
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fenugreek Use in Mothers of Preterm on Breast Milk Production and Macronutrient Content
- ClinicalTrials.gov ID
- NCT02384655
- Acronym / sponsor ID
- 0652-14-TLV-RM
- Keywords
- Preterms, Breastfeeding, Lactation, Macronutrients
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 11 Mar 2015 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fenugreek | Experimental | Drug: Fenugreek seed mealMothers will take fenugreek for 14 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fenugreek seed meal3x3 capsules of fenugreek seeds per day for 14 days | Drug | Fenugreek |
Primary outcome
Change in daily volume of expressed milk
Time frame: at day 0, 3, 7, 10, 14
1 secondary outcome
Change in Macronutrient content analysis of breastmilk
Time frame: at day 0, 3, 7, 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
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Skin Conductance in Ventilated Preterms
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Relation Between Prostaglandin E2 Metabolite Levels and the Development of Hemodynamically Significant Patent Ductus Arteriosus in Preterm Neonates
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronella Marom, MD principal investigator
Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fenugreek seed meal in people with Preterms and Lactation, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronella Marom, MD (+97236925690, ronellam@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily volume of expressed milk (time frame: at day 0, 3, 7, 10, 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.