Clinical trials: Human Milk/Breastfeeding
Low Milk Supply, Pre-diabetes
Metformin to Augment Low Milk Supply (MALMS) Study
Most new mothers in the United States will start off breastfeeding. For some mothers, despite following best practices, they are not able to meet their breastfeeding goals due to unexplained low milk supply.
- Conditions
- Low Milk Supply, Pre-diabetes, Insulin Resistance, Suppressed Lactation
- Trial name
- MALMS (NCT02179788)
- Testing
- Standard care, Metformin
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Infantile Colic, Breast Feeding
The Role of Human Milk Oligosaccharides and Microbiomes on Infantile Colic and Atopic Dermatitis in Term Infants
Background: Human milk oligosaccharides (HMO) and microbiota are both key factors for infants to shape the gut flora and develop the immune system.
- Conditions
- Infantile Colic, Breast Feeding, Atopic Dermatitis, Infant Formula
- Trial name
- NCT05992493
- Where
- Taiwan
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- National Cheng-Kung University Hospital
Breast Milk Expression
Krill Oil Supplementation: Effects on Breast Milk Composition
Docosahexaenoic acid (DHA) belongs to long-chain polyunsaturated fatty acids (LCPUFAs) category and is a major building block for neuronal and retinal membranes, playing a crucial role in brain and visual development within the…
- Trial name
- NCT03583502
- Testing
- krill oil and fish oil supplement
- Where
- Italy
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Breastfeeding, Human Milk
Human Milk Lipid Profile Assessment and Influences of Mother's Diet
Human milk profile is unique and diet exerts a pivot role in determing its composition. As a rule, nursing mothers do not receive specific nutritional indications aimed at improving the lipid profile of milk, despite the…
- Conditions
- Breastfeeding, Human Milk, Diet Habit, Fatty Acid
- Trial name
- NCT03808207
- Testing
- Dietary counseling and DHA dietary increase in breastfeeding mothers
- Where
- Italy
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Università degli Studi di Ferrara
Pediatric Obesity, Recruitment
The BEACH Interview Study- Pregnant and Breastfeeding Mothers
Interview pregnant and breastfeeding mothers in the Gainesville, FL area to optimize; clinical study recruitment and retention, patient-centered outcomes, and stool collection procedures.
- Trial name
- BEACH (NCT03036696)
- Testing
- Pregnant Mothers Interview, Breastfeeding Mothers Interview
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- University of Florida
Preterm Infant, Lactation
Melatonin Degradation Rate in Human Milk
Our long term hypothesis is that giving premature infants breast milk that was pumped during the night and has high concentration of melatonin will improve outcome of several clinical conditions related to premature infants.
- Trial name
- NCT03591341
- Testing
- melatonin level in pumped breast milk
- Where
- Israel
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Carmel Medical Center
Small for Gestational Age at Delivery, Gestational Diabetes
The CanDo (Canadian Donor Milk) Trial
The goal of this clinical trial is to learn about the impact of donor milk vs formula supplementation on human milk feeding and the health outcomes of infants who require supplementation in well-baby units.
- Conditions
- Small for Gestational Age at Delivery, Gestational Diabetes, type1diabetes, Type2diabetes
- Trial name
- NCT06315127
- Testing
- Human donor milk, Formula
- Where
- 3 sites in Canada
- Volunteers
- 112 people
- Sponsor
- Mount Sinai Hospital, Canada
Visfatin Levels in Maternal Milk Samples, Birth Weight
Levels of Visfatin/NAMPT in Human Milk
Visfatin, released in maternal milk at different concentrations related to the maternal conditions, could act as a biomarker with a prognostic/predictive value to determine different newborn clinical conditions, particularly the…
- Trial name
- VISFAMILK (NCT06487286)
- Testing
- observational study
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Paolo Manzoni Study Group
Milk, Human
Breast Milk Composition: Interindividual Variations and Dietary Factors in Galicia
Human milk is not a uniform body fluid, but quite the opposite, its composition changes continuously adapting to the requirements of the newborn.
- Trial name
- NCT03245697
- Volunteers
- 102 people
- Sponsor
- University of Santiago de Compostela
Human Milk Microbiome, Bacterial Growth
Milk in Life Conditions (MiLC): Bacterial Composition of Human Milk Pumped and Stored in "Real-Life" Conditions
The MiLC trial is a randomized control trial of two different breast pump set-ups: mother's own and sterile. The objective of this trial is to investigate the bacterial composition of human milk pumped and stored in "real-life"…
- Trial name
- MiLC (NCT03123874)
- Testing
- Sterile pump set-up, Mother's Own pump set-up
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Cornell University
Necrotising Enterocolitis Neonatal
Effects of Implementation of a Care Bundle on Rates of NEC and Own Mother's Milk Feeding in the East Midlands
Necrotising enterocolitis (NEC) is a life-threatening gut disease in babies born early. Feeding preterm babies their own mother's milk prevents NEC.
- Trial name
- EMNODN-NEC (NCT05934123)
- Testing
- EMNODN NEC Care Bundle
- Where
- United Kingdom
- Volunteers
- 53,600 people
- Sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
Breast Milk Collection
Investigating Lipid Peroxidation Products in Donor Human Milk
This study will quantify lipid peroxidation products (malondialdehyde, 4 hydroxy-2-nonenal, hexanal, and 8-iso-PGF2α), fatty acid content, and antioxidant capacity in donor human milk sampled from two neonatal units in the UK.
- Trial name
- LIMIT (NCT03573531)
- Testing
- Laboratory analysis
- Where
- 3 sites in United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bournemouth University
Obesity
The Effects of Natural Sugars in Breast Milk on Healthy Infant Growth and Development
This study will investigate the effects of breastfeeding and breastmilk composition on infant gut microbiome development as well as obesity and cognitive outcomes.
- Trial name
- NCT04434027
- Where
- United States
- Volunteers
- 221 people, healthy volunteers welcome
- Sponsor
- University of Southern California
Neurodevelopmental Outcomes of VLBW Infants
Donor Human Milk and Neurodevelopmental Outcomes in Very Low Birthweight (VLBW) Infants
Breastfeeding is an important health-promoting behavior. Human milk is the ideal diet for all infants, optimizes intellect, and provides protection against infectious and atopic diseases in childhood as well as decreasing risks…
- Trial name
- NCT01232725
- Testing
- Donor Human Milk
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- Tarah T Colaizy
Premature, Preterm Infant Health
Vitamin A Supplementation and Breast Milk Vitamin A Levels in Mothers of Preterm Infants
Preterm infants are at increased risk of vitamin A deficiency because they are born with low vitamin A stores and depend largely on breast milk to meet their nutritional needs.
- Conditions
- Premature, Preterm Infant Health, Vitamin A Deficiency, Human Milk
- Trial name
- VITAL (NCT07736768)
- Testing
- Oral multivitamin containing vitamin A
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Mississippi Medical Center
Pediatric Obesity
Pediatric Obesity and the Infant Microbiome (BEACH)
The impact of breastfeeding on the infant microbiome in vaginally and Cesarean delivered offspring from obese and normal weight mothers.
- Trial name
- BEACH (NCT02843087)
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- University of Florida
Pregnancy, Lactation
The Role of Human Milk in Development of Breast Fed Child's Intestinal Microbiota
The ideal food for normal infants is human milk. In addition, breast milk has been shown to be a continuous source of commensal, and⁄or probiotic bacteria to the infant gut where they play a key role in the initiation and…
- Trial name
- MYMILK (NCT01548313)
- Where
- Slovenia
- Volunteers
- 294 people, healthy volunteers welcome
- Sponsor
- University of Ljubljana
Breastmilk, Breastmilk Expression
Relationship Between Nutritional Consumption of Breastfeeding Mothers and Breast Milk Composition During Lactation
This study seeks to answer the question of the effect of maternal diet during lactation on breast milk composition. This study was conducted with 31 mothers who were hospitalized in Şanlıurfa Education and Research Hospital due…
- Conditions
- Breastmilk, Breastmilk Expression, Maternal Nutrition
- Trial name
- NCT07036094
- Testing
- Manual breast milk expression
- Where
- Turkey (Türkiye)
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Sakarya University
Pumping, Breast, Milk, Human
Reducing Disparity in Receipt of Mother's Own Milk in Very Low Birth Weight Infants
In the US, the burden of very low birth weight (VLBW; <1500 g) birth is borne disproportionately by black (non-Hispanic black/African American) mothers who are 2.2-2.6 times more likely than nonblack mothers to deliver VLBW…
- Conditions
- Pumping, Breast, Milk, Human, Infant, Very Low Birth Weight, Preterm Birth
- Trial name
- ReDiMOM (NCT04540575)
- Testing
- NICU Acquires MOM, Mother Provides MOM
- Where
- United States
- Volunteers
- 362 people
- Sponsor
- Rush University Medical Center
Breastfeeding, Bottle Feeding
The Effect of Oral Feeding Model With a Chronobiological Approach in Preterm Infants
As in healthy term babies, the ideal food for preterm infants and sick term babies is breast milk. There are many studies indicating that the composition of breast milk can vary from mother to mother, according to the gestational…
- Conditions
- Breastfeeding, Bottle Feeding, Preterm, Chronobiology Disorders
- Trial name
- NCT04992819
- Testing
- Chronobiological Approach Nutrition Model
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Okan University