Clinical trials: Human Milk, open to volunteers
Very Preterm Infants (<32 Weeks of Gestation)
Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants
The AdVEMPrem study is exploring whether tiny particles called extracellular vesicles (EVs), which are naturally found in human milk, can help protect very premature babies from serious gut problems such as necrotizing…
- Trial name
- AdVEMPrem (NCT07402083)
- Testing
- Donor human milk extracellular vesicles (DHM-EVs)
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Instituto de Investigacion Sanitaria La Fe
Prematurity
Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants
This prospective randomized controlled trial aims to investigate whether feeding very low birth weight (VLBW) infants with Mother's own milk (MOM) supplemented with either preterm (PDM) or term donor milk (TDM), when MOM is…
- Trial name
- NCT05675397
- Testing
- donor human milk
- Where
- 2 sites in Greece
- Volunteers
- 200 people
- Sponsor
- National and Kapodistrian University of Athens
Preterm Infants
Protocol-driven Nutrition in Preterm Infants
The project is a national, prospective, multicenter, interventional pilot project focused on protocol-driven nutrition in preterm infants in the Czech republic.
- Trial name
- NCT07364500
- Testing
- Nutrition plan supported by advanced clinical nutrition software
- Where
- 5 sites in Czechia
- Volunteers
- 400 people
- Sponsor
- Institute of Health Information and Statistics of the Czech Republic
Maternal Stress
Impact of Vitamin D Supplements on Mental Health and Milk Composition in Mothers Living in Idaho
Mothers of preterm infants experience exaggerated emotional stressors compared to those typically associated with new motherhood, making these women particularly vulnerable to postpartum depression.
- Trial name
- NCT06919718
- Testing
- Vitamin D (Cholecalciferol )
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of Idaho
Breast Feeding, Human Milk
UmbrelLACT Study: Clinical Lactation Study on the Exposure to Medicines Via Human Milk
The goal of this observational study is to determine the concentration of medicines in human milk during maternal medicine intake.
- Trial name
- UmbrelLACT (NCT06042803)
- Testing
- Human milk collection, Optionally: maternal blood sample, Optionally: child blood sample
- Where
- Belgium
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Parents of Toddlers in Daycare Who Wish to Continue to Provide Breastmilk Past the Age of 1 Year, Daycare Providers Working With Children Between the Ages of 1 and 3 Years Who Still Receive Breastmilk
Thermoses as a Way to Provide Human Milk to Toddlers in Daycare
Parents and daycare providers for children between the ages of 1 and 3 years old at participating daycares will be asked to join this study.
- Trial name
- NCT07540871
- Testing
- Thermos 1, Thermos 2, Thermos 3
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of Florida
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
Obesity and Overweight, Breastfeeding, Exclusive
Impact of Chia Seeds on Human Breast Milk Composition
The investigators' over-arching hypothesis is that mechanical and compositional properties of chia seeds supplemented during lactation diminish obesity-induced intestinal inflammation and barrier dysfunction.
- Trial name
- NCT07343908
- Testing
- Chia seeds
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- University of Oklahoma
Breastfeeding, Dietary Intervention
Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready, Set, Nourish Study)
This study is about preparing women with excessive weight to have better breastfeeding outcomes. By doing this study, the investigators hope to learn more about how hand expression of breast milk or colostrum during pregnancy can…
- Conditions
- Breastfeeding, Dietary Intervention, Milk Expression, Breast
- Trial name
- RSN (NCT06929091)
- Testing
- Lactation Support and ABME, Lactation Support and meal plan, Lactation Support
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Arkansas Children's Hospital Research Institute
Postpartum, VTE Prophylaxis
Excretion of Rivaroxaban in Human Breast Milk
The purpose of this study is to investigate the distribution of rivaroxaban into human milk at both therapeutic and prophylactic doses, and over time with repeated dosing.
- Conditions
- Postpartum, VTE Prophylaxis, VTE (Venous Thromboembolism), Rivaroxaban
- Trial name
- LACT (NCT06831474)
- Testing
- Rivaroxaban 10 MG Oral Tablet, Rivaroxaban 20 MG Oral Tablet
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Thomas Jefferson University
Docosahexaenoic Acid Content of the Participants, Docosahexaenoic Acid Content of the Breast Milk
Effectiveness of Nutritional Resources for Milk Donors
Maternal diet influences breast milk nutritional profile; however, a national survey undertaken by the researchers revealed that non-for-profit donor milk banks in the U.K. do not provide specific dietary information to donors.
- Trial name
- VITAMIN (NCT07042009)
- Testing
- Nutritional resources, Milk docosahexaenoic acid levels
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Roehampton
Prematurity
Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL/kg/day on the body composition outcomes of moderately preterm infants born between 27…
- Trial name
- MAGIC (NCT06420531)
- Testing
- Human milk
- Where
- 4 sites in United States
- Volunteers
- 486 people
- Sponsor
- University of Alabama at Birmingham
Human Milk Nutrition
Determinants of the Nutritional Composition of Donor Human Milk
Human milk is the most complete and correct way to feed a newborn, as it provides all the nutrients and bioactive factors essential for adequate growth and neurodevelopment.
- Trial name
- NCT06904924
- Where
- Portugal
- Volunteers
- 80 people
- Sponsor
- Universidade do Porto
Ageing Well, Neuromuscular Function
Effect of 12-week Milk Fat Globule Membrane Supplementation on the Human Muscle Function of Healthy, Recreationally Active Adults
The main aim of this study is to understand if chronic supplementation (12 weeks) of a milk fat globule membrane containing supplement, called bioactive whey protein concentrate, improves human muscle function greater than a…
- Trial name
- NCT06573749
- Testing
- Bioactive whey protein concentrate, Whey protein isolate supplement
- Where
- United Kingdom
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Loughborough University
Breastfeeding, COVID-19 Infection
Researchers At UC San Diego Are Learning About the Benefits of Human Milk and How It Influences Infant and Child Health
The purpose of the UCSD Human Milk Biorepository is to establish and maintain a repository of breast milk samples that can be used to learn more about how breast milk influences infant and child health.
- Conditions
- Breastfeeding, COVID-19 Infection, COVID-19 Vaccine, Remdesivir
- Trial name
- NCT05553743
- Testing
- COVID-19 Exposure, Antibiotic
- Where
- United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Growth & Development, Breastfeeding Satisfaction
Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center
Introduction: Evidence supports that exclusive breastfeeding (EBF) is the most beneficial method of infant feeding up to 6 months of age. The practice confers numerous advantages for the infant and the mother.
- Conditions
- Growth & Development, Breastfeeding Satisfaction, Breastfeeding Consultancy Training, Breastfeeding Duration
- Trial name
- ALM-AP (NCT07309510)
- Testing
- breastfeeding counseling
- Where
- Spain
- Volunteers
- 160 people
- Sponsor
- Fundación Pública Galega de Investigación Biomédica INIBIC
Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant
Optimizing Nutrition and Milk (Opti-NuM) Project
Early nutrition critically influences growth, neurodevelopment and morbidity among infants born of very low birth weight (VLBW), but current one-size-fits-all feeding regimes do not optimally support these vulnerable infants.
- Conditions
- Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant, Nutritional Requirements, Human Milk Fortification
- Trial name
- Opti-NuM (NCT06870981)
- Testing
- Opti-NuM is an observational secondary use of data/samples study, the investigators will analyze information and specimens from the MaxiMoM platform RCTs. No interventions form part of this study.
- Where
- 6 sites in United States, Canada
- Volunteers
- 1,100 people
- Sponsor
- The Hospital for Sick Children
Breastfeeding, Exclusive
Synergistic Activity of Human Milk Nutrients and Infant Cognition
Purpose: To establish a whole food, egg, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. There will be 84 breastfeeding dyads, 3 months postnatal.
- Trial name
- NCT03838536
- Testing
- Whole Egg Powder, Egg White Powder
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Cow's Milk Protein Allergy (CMPA), Food Hypersensitivity
SMASH: Study to Evaluate the Clinical Efficacy of an Extensively Hydrolysed Infant Formula With Synbiotics and a Human Milk Oligosaccharide (HMO) in Infants With Cow's Milk Protein Allergy (CMPA)
Cow's milk protein allergy (CMPA) is one of the most common food allergies in infants, with an estimated prevalence between 2% and 5%.
- Conditions
- Cow's Milk Protein Allergy (CMPA), Food Hypersensitivity, Infant Nutrition Disorders, Gut Microbiota
- Trial name
- SMASH (NCT07342621)
- Where
- 13 sites in Spain
- Volunteers
- 41 people
- Sponsor
- Outcomes'10
Healthy Infants
Efficacy of Two HMOs in Chinese Infants
This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier…
- Trial name
- NCT06361719
- Testing
- Experimental Group (EG), Control Group (CG)
- Where
- China
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)