Clinical trials: Breast Feeding
Healthy Lactating Mother
Study to Learn About the Effect of Elevit (a Food Supplement Containing Several Vitamins, Minerals, Lutein and DHA) on the Nutrient Content in the Breast Milk and Blood of Women During Breastfeeding Period and on Babies' Physical Growth Parameters
The aim of the study is to learn about the effect of multi-micronutrient, lutein and DHA supplementation (Elevit Breastfeeding \& Postnatal Care) on the breast milk nutrient composition and babies physical growth parameters.
- Trial name
- NCT04462939
- Testing
- Elevit Breastfeeding & Postnatal Care
- Where
- 3 sites in Germany
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Bayer
Multiple Sclerosis, Clinically Isolated Syndrome
A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab
This study will evaluate the pharmacokinetics of ocrelizumab in the breastmilk of lactating women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] treated with…
- Trial name
- SOPRANINO (NCT04998851)
- Testing
- Ocrelizumab
- Where
- 8 sites in United States, Spain and 1 more
- Volunteers
- 26 people
- Sponsor
- Hoffmann-La Roche
Breast Feeding, Milk, Human
A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk
The current longitudinal (max. 2-year) observational cohort study in 120 lactating mothers and their newborns will make it possible to explore human milk composition across different lactation stages, between different human milk…
- Trial name
- NCT05979532
- Where
- Netherlands
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Breastfeeding, Exclusive Breastfeeding
KULEA-NET: A Mobile Application for African American/Black Mothers to Promote Exclusive and Continuous Breastfeeding
KULEA-NET is a mHealth intervention that will improve knowledge, self-efficacy, and intentions related to exclusive breastfeeding (EBF).
- Trial name
- KULEA-NET (NCT05985876)
- Testing
- KULEA-NET application, Control Group: Usual Care
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Benten Technologies, Inc.
MASH - Metabolic Dysfunction-Associated Steatohepatitis
Rezdiffra Pregnancy and Lactation Registry
To evaluate pregnancy and clinical outcomes in women with NASH and their infants after exposure to Rezdiffra at any time during pregnancy and/or lactation.
- Trial name
- NCT07541469
- Testing
- Rezdiffra
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Phenylketonuria, Maternal
A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding
This is a Phase 4 observational study designed to assess the impact of Palynziq ® (pegvaliase) treatment in pregnant women with PKU and on their offspring who were exposed to pegvaliase at any time during pregnancy and…
- Trial name
- PALomino (NCT05579548)
- Testing
- Pegvaliase
- Where
- 4 sites in United States, Canada and 2 more
- Volunteers
- 50 people
- Sponsor
- BioMarin Pharmaceutical
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
Healthy, Breast Pumping
Engineering Evaluation of a Breast Pump Device
This research involves feasibility testing of design concepts to support device development of an electric breast pump. The purpose is to evaluate a prototype device for feasibility purposes and not health outcomes.
- Trial name
- NCT05222581
- Testing
- Prototypes of breast shield and Freedom Double Electric Breast Pump
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Momtech Inc.
Glycogen Storage Disease, Pompe Disease
Pompe Lactation Sub-Registry
The objective is to determine if alglucosidase alfa is present in breast milk from mothers with Pompe Disease being treated with alglucosidase alfa and to measure breast milk production and composition in women with Pompe Disease…
- Trial name
- NCT00566878
- Testing
- alglucosidase alfa
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Genzyme, a Sanofi Company
Lactation
Lactation Fortification Study
To investigate the impact of nutrient supplementation during lactation on levels in breast milk.
- Trial name
- NCT01747668
- Testing
- Similac Prenatal Vitamin soft-gel capsule
- Where
- 6 sites in United States
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Breast Fed Infants
Plasma Profile of Exclusively Breastfed Infants
To characterize nutrient levels in breastfeeding infants and their mothers.
- Trial name
- NCT01669655
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Diabetes Mellitus, Type 2
A Research Study to See How Much Semaglutide and SNAC is in the Milk of Healthy, Breastfeeding Women Taking Semaglutide Tablets
Participants in the study, will receive the study drug once daily for 10 days in tablet form for oral (by mouth) intake. On day 1 to 5 the tablet will contain 3 mg semaglutide, and on day 6-10 the tablet will contain 7 mg…
- Trial name
- NCT04817644
- Testing
- Oral semaglutide
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Lactation, Inflammatory Bowel Disease
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
The main purpose of this study is to assess the amount of mirikizumab in breast milk in women who are breastfeeding who are receiving stable maintenance doses of mirikizumab for an approved indication.
- Trial name
- NCT07612267
- Testing
- Mirikizumab
- Where
- 20 sites in United States, Canada and 5 more
- Volunteers
- 14 people
- Sponsor
- Eli Lilly and Company
Healthy
A Study of a Probiotic Food Supplement Containing B. Infantis (EVC001) in Healthy Breastfed Infants at Risk of Developing Atopic Dermatitis
The purpose of this study is to assess the effect of B. infantis (EVC001) versus placebo supplementation, in healthy breastfed infants at risk of developing atopic dermatitis (AD), on cumulative incidence of physician-diagnosed…
- Trial name
- NCT04662619
- Testing
- B. infantis
- Where
- Finland
- Volunteers
- 273 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
Healthy Participants
A Study to Learn About the Medicine (PF-07321332 or Nirmatrelvir/Ritonavir) in Healthy Lactating Women
The main purpose of this study is to measure the level of active ingredient of the study medicine (nirmatrelvir) that is secreted in human breast milk when it is given to healthy breastfeeding women.
- Trial name
- NCT05441215
- Testing
- nirmatrelvir, ritonavir
- Where
- Belgium
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer
Breastfeeding, Patient Simulation
Comparison of Baby Dolls for Teaching Newborn Positioning and Attachment
In this baby doll comparison study, clinical lactation specialists will complete two back-to-back video-based simulations (telesimulations) focused on newborn positioning and attachment.
- Conditions
- Breastfeeding, Patient Simulation, High Fidelity Simulation Training
- Trial name
- NCT04715724
- Testing
- Positioning and Attachment video-based simulation (telesimulation)
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- LiquidGoldConcept
Healthy Growth
Growth, Tolerance, and Safety Study of Healthy Term Infants Consuming a New Organic Cow's Milk-Based Infant Formula
The goal of this study is to demonstrate that healthy term babies who are fed Bobbie's study formula grow at the same rate as those fed with an existing cow's milk formula.
- Trial name
- NCT05783037
- Testing
- New Organic Infant Formula, Commercial Organic Infant Formula
- Where
- United States
- Volunteers
- 394 people, healthy volunteers welcome
- Sponsor
- Bobbie Baby, Inc
Lactation
Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set in Home Use
The overall purpose of this study is to evaluate the reliability and usability of the reusable BrownieForSymphony pump set in home use.
- Trial name
- ESPII (NCT02492139)
- Testing
- Pumping CE-marked Symphony Pumpset, Pumping BrownieForSymphony Pumpset
- Where
- Switzerland
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Medela AG
Transthyretin Amyloidosis
The Eplontersen Pregnancy and Lactation Outcomes Study
The overall objective of this DPSS is to describe the occurrence of pregnancy and maternal complications, adverse effects on the developing fetus and neonate, and adverse effects on the infant associated with exposure to…
- Trial name
- EPPRO (NCT07205666)
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- AstraZeneca
Lactation
Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set
The primary objectives of this study is to evaluate how professionals rate the reliability and usability of the reusable BrownieForSymphony pump set.and the current used Symphony pump set 4.2 Secondary Objectives The secondary…
- Trial name
- ESP (NCT02496429)
- Testing
- BrownieForSymphony use
- Where
- 2 sites in Germany
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Medela AG