Clinical trials: Breastfeeding
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
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 Milk Collection
Odour Characteristics of Human Breast Milk of Chinese Mothers
It is well known that breast milk exerts many positive effects on the general health, growth and development of infants. When breastfeeding is not possible, infant formula is considered to be an effective substitute to satisfy…
- Trial name
- NCT05133466
- Where
- China
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
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
Healthy Lactating Women
A Study Of Pregabalin (Lyrica) Drug Levels In Urine, Plasma And Breast Milk Of Healthy Lactating Women
This is a pharmacokinetic study to determine the safety and tolerability of pregabalin in healthy lactating women. The objectives are to determine whether pregabalin is secreted in breast milk and if so, to characterize…
- Trial name
- NCT01727791
- Testing
- pregabalin (Lyrica)
- Where
- Belgium
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy Volunteer
A Study to Find Out How BIIB141 (Omaveloxolone) Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping Milk
In this study, researchers will learn how BIIB141, also known as omaveloxolone or SKYCLARYS®, moves through the body. This is a drug available for doctors to prescribe for patients with Friedrich's Ataxia.
- Trial name
- NCT06612879
- Testing
- Omaveloxolone
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Biogen
Breastfeeding, Hypertrophic Cardiomyopathy
Mavacamten Pregnancy Surveillance Program
The purpose of this observational pregnancy safety study is to assess maternal, fetal, and infant outcomes after exposure to mavacamten at any time during pregnancy and/or breastfeeding.
- Conditions
- Breastfeeding, Hypertrophic Cardiomyopathy, Pregnancy Related
- Trial name
- NCT05939700
- Testing
- Mavacamten
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Bristol-Myers Squibb
Breast Feeding
Breastfeeding Intervention Study
To evaluate the benefits of a lactation support intervention, in conjunction with maternal nutritional supplementation.
- Trial name
- NCT02016586
- Testing
- Maternal Nutritional Supplement
- Where
- 18 sites in Vietnam
- Volunteers
- 228 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
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
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
Pilot Study of the FEEDBACK System for Use With Infants in the Neonatal Intensive Care Unit at University of Virginia
The purpose of this study is to assess the accuracy of FEEDBACK for measuring breastmilk intake of a pre-term baby. Mothers and babies will use the FEEDBACK system during a breastfeeding session in the NICU.
- Trial name
- NCT03702686
- Testing
- FEEDBACK System
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Molex Ventures LLC
Pregnancy Related
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12…
- Trial name
- NCT06258902
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Ipsen
Healthy
A Study to Learn How the Study Medicine Called Zavegepant is Taken Up Into Blood and Breast Milk of Healthy Breast-Feeding Women
The purpose of the study is to look at the amount of zavegepant that is present in breast milk after single dose of zavegepant is sprayed through the nose in healthy breast-feeding women.
- Trial name
- NCT06453356
- Testing
- Zavegepant 10mg
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
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
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
Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
The purpose of this study is to assess stool consistency, in combination with additional health-related parameters including gastrointestinal tolerance and health-related quality of life, in a large sample of Chinese infants.
- Trial name
- NCT01370967
- Testing
- Study formula feeding, Human milk feeding, Mixed feeding
- Where
- 24 sites in China
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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)
Friedreich Ataxia
A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babies
In this study, researchers will learn more about the safety of BIIB141, also known as omaveloxolone or SKYCLARYS. This is a drug available for doctors to prescribe for people with Friedrich's Ataxia, also known as FA.
- Trial name
- NCT06628687
- Testing
- Omaveloxolone
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Biogen
Healthy
Immune Health Biomarkers and Fecal Microbiota in Filipino Breastfed Infants
This will be a prospective observational study aiming to investigate immune health biomarkers and fecal microbiota in 48-60 Filipino breastfed infants from birth to 12 months of age.
- Trial name
- NCT06708559
- Testing
- Breast-fed infants
- Where
- Philippines
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)