Clinical trials: Lactation
Lactating Women, Breastfed Infants
A Lactation Study in Women Receiving Treatment With Ozanimod
The purpose of this study is to assess the concentrations of ozanimod and its major metabolites in breast milk and the effects on breastfed infants.
- Trial name
- NCT06181630
- Testing
- Breast milk, plasma, and blood samples
- Where
- United States
- Sponsor
- Bristol-Myers Squibb
Breast Milk Collection
Establishment of the Breast Milk Database in China
Collect breast milk samples in various administrative regions of China to measure the nutrients in breast milk; analyze the composition of nutrients; and establish the database of breast milk in China.
- Trial name
- NCT03675204
- Testing
- No intervention
- Volunteers
- 1,800 people, healthy volunteers welcome
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
Breastfeeding, Patient Simulation
Evaluation of Health Professional Learners' Competence in Newborn Positioning and Attachment Following a Standardized Patient-led Lactation Skills Workshop
Evaluating newborn positioning and attachment is a key skill for maternal-child healthcare providers. Trainees have limited opportunities to practice this skill in their clinical rotations due to a lack of access to lactating…
- Trial name
- NCT04717128
- Testing
- Breastfeeding Skills Workshop
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- LiquidGoldConcept
Anaemia
Safety and Efficacy Study of a Food Supplement for Pregnant and Lactating Women
The purpose of this study is to determine whether a food supplement consisting of vitamins, minerals and fish oil taken during and after pregnancy can decrease the need for additional iron supplementation due to anemia during…
- Trial name
- NCT02190565
- Testing
- Food supplement
- Where
- Sweden
- Volunteers
- healthy volunteers welcome
- Sponsor
- Oriflame Cosmetics AB
Healthy Volunteers
Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Female Adult Volunteers
This study will assess adverse events and compare how ubrogepant and atogepant tablets move through the body of healthy adult lactating female participants.
- Trial name
- NCT05892757
- Testing
- Atogepant, Ubrogepant
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- AbbVie
Norovirus Infections
A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants
The primary objective of this study is to evaluate the safety and tolerability of an oral bivalent GI.1/GII.4 norovirus vaccine administration in healthy lactating female participants and to assess the short-term immunogenicity…
- Trial name
- NCT07254728
- Testing
- VXA-G1.1-NN, VXA-G2.4-NS
- Where
- 5 sites in South Africa
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Vaxart
Infant Term Birth
Breastfeeding Study
The purpose of this study is to evaluate the stool consistency and microbiota composition of healthy breastfed infants.
- Trial name
- NCT03387124
- Testing
- Breastfed infants
- Where
- Philippines
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Lactation
RE104 Clinical Lactation Study
The purpose of this study is to obtain data necessary to characterize the elimination of RE104 and metabolites from breastmilk of health lactating volunteers to support a regulatory assessment of when mothers can safely return to…
- Trial name
- NCT06659263
- Testing
- RE104 for Injection
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Reunion Neuroscience Inc
Breast Pumping
Initiate Study Evaluating if Mothers Who Are Both Breastfeeding and Pumping in the First Days After Delivery Report Improved Comfort Levels With the New Symphony Program Card
The study hypothesizes that mothers who are both breastfeeding and pumping in the first days report improved comfort levels with the new Symphony program card INITIATE 2.0 compared to the standard of care.
- Trial name
- Initiate (NCT04619212)
- Testing
- breast pumping as per SoC but on new software for the pump
- Where
- Netherlands
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Medela AG
Childhood Obesity
Josef Ressel Centre Perinatal Programming
Background: Metabolic imprinting through early childhood nutrition seems to play an important role in the aetiology of obesity. Overweight at age two and later in life is associated with excessive weight gain as early as three…
- Trial name
- JRP (NCT03634930)
- Testing
- observation
- Where
- Austria
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Moenie van der Kleyn
Breast Milk Collection
Human Milk Sample Composition in Israeli Mothers and Correlation With Their Diet
The study will collect human milk from 100 mother of term infants 2-3m after delivery and from 50 mothers of preterm infants 14 and 30 days after delivery.
- Trial name
- NCT02596295
- Where
- Israel
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Enzymotec
Fabry Disease, Alpha Galactosidase A Deficiency
Study of the Effects of Fabrazyme Treatment on Lactation and Infants
The study was planned for up to 2 years (24 months). Planned full participation for both mother and infant was 24 months, planned full participation of mother and development of infant was 24 months, while planned full…
- Trial name
- NCT00230607
- Testing
- agalsidase beta
- Where
- 5 sites in United States, Austria and 1 more
- Volunteers
- 7 people
- Sponsor
- Genzyme, a Sanofi Company
Fabry Disease
A Global Prospective Observational Study of Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding
This is a global prospective observational study of women with Fabry disease and their infants during pregnancy and/or breastfeeding.
- Trial name
- NCT04252066
- Testing
- migalastat
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Amicus Therapeutics
Infant Development
Effects of an Infant Formula on Growth, Safety and Efficacy for Healthy Term Infants
The purpose of this study is to evaluate that a Cow's Milk Based Infant Formula A2 Containing Both OPO and CPP for healthy term infants supports age-appropriate growth.
- Trial name
- NCT04749290
- Testing
- Study Formula
- Where
- 2 sites in China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Bunge Loders Croklaan
Breastfeeding, Exclusive
MILC: A Comprehensive Mobile Application That Addresses the Breastfeeding Challenges of Low-income Hispanic Mothers
The innovative platform MILC is designed to provide an integrated and comprehensive professional and social support network with personalized breastfeeding (BF) education to target exclusive breastfeeding (EBF) and any BF…
- Trial name
- MILC (NCT06520696)
- Testing
- MILC application, Usual care
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Benten Technologies, Inc.
Breast Feeding
Assessment of Annabella Breast Pump Performance
This is an interventional, prospective, randomized, comparative, two-period cross over study to evaluate the performance of Annabella breast pump against a control breast pump.
- Trial name
- NCT04363073
- Testing
- Annabella Breast Pump, Control Breast Pump
- Where
- Israel
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Annabella Tech Ltd
Healthy
A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women
The main purpose of this study is to assess the concentrations of nipocalimab (pharmacokinetics [PK]) in the breast milk after administration of a single dose of nipocalimab into the vein, in healthy lactating women.
- Trial name
- NCT07669077
- Testing
- Nipocalimab, Breast Milk Sampling
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Breast Feeding, Breast Milk Expression
A Cohort Study on Milk Composition, Health Outcomes, and Feeding Practices of Chinese Mothers and Infants
This is a cohort study to understand the changes of breastmilk composition in the first six months after birth of Chinese infants.
- Trial name
- Phoenix (NCT05235412)
- Testing
- Not applicable: Observational study without any interventions.
- Where
- China
- Volunteers
- 769 people, healthy volunteers welcome
- Sponsor
- Danone Nutricia
Newborns, Breast Milk Expression
Newborns Supplemented With Gentle-UHT Donor Milk
This study evaluates the effects of providing breastfeeding mothers with Gentle-UHT donor human milk (GHM) after discharge to bridge the gap during delayed onset lactation, to support an exclusive human milk diet and continued…
- Trial name
- NCT04492579
- Testing
- Gentle-UHT donor human milk supplementation
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- LactaLogics, Inc
Breast Pumping
Clinical Investigation to Assess the Performance of the Eureka Electric Breast Pump in Mothers Breastfeeding Their Healthy Term Infant
Babies are the best in class in order to get human milk out of a lactating breast. With this in mind, Philips has developed the a new electric breast pump, attempting to mimic the babies sucking behavior.
- Trial name
- EUREKA (NCT03960190)
- Testing
- Using Eureka Breast Pump with Expression Kit
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Philips Consumer Lifestyle