Clinical trials: Breastfeeding
Formula Feeding of Healthy Full Term Infants, Breast Feeding of Healthy Full Term Infants
Impact of Infant Feeding on Newborn Metabolomic Profile
The purpose of this study is the evaluation with untargeted modalities, of the urine metabolomic profile in a group of infants fed with a standard formula, a group of infants fed with a formula supplemented with functional…
- Trial name
- NCT01606683
- Testing
- Infant formula with GOS, beta-palmitate, acidified milk, Standard infant formula without functional ingredients, No intervention
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Heinz Italia SpA
Lactation
An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females
This is an open label study to investigate PK of tenapanor and AZ13792925 in breast milk of lactating female subjects.
- Trial name
- NCT06203444
- Testing
- Tenapanor
- Where
- 2 sites in United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Ardelyx
Influenza
Observational Study on the Pharmacokinetics of Oseltamivir in the Treatment of Influenza During Lactation
The main purpose of this study is to assess the potential exposure of neonates to oseltamivir during lactation by examining oseltamivir concentrations in maternal blood, urine, and breast milk in breastfeeding women who are…
- Trial name
- NCT01130636
- Testing
- Oseltamivir
- Where
- 2 sites in Hungary
- Volunteers
- 6 people
- Sponsor
- Pharmahungary Group
Mastitis, Breast Milk
Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis
The aim of the present study is to evaluate the effect of consumption during pregnancy and the lactation period of the probiotic L. fermentum CECT5716 on the incidence of mastitis.
- Conditions
- Mastitis, Breast Milk, Lactation, Women's Health
- Trial name
- NCT04032899
- Testing
- Lactobacillus fermentum CECT5716, Maltodextrin
- Where
- 3 sites in Spain
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Biosearch S.A.
Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis
A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.
- Conditions
- Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, Axial Spondyloarthritis, Hidradenitis Suppurativa
- Trial name
- BE CARING (NCT06888193)
- Testing
- Bimekizumab
- Where
- 14 sites in United States, Canada and 3 more
- Volunteers
- 20 people
- Sponsor
- UCB Biopharma SRL
Non-Diabetic, Females Who Are Not Pregnant or Breast Feeding
The Wellness Transformation Network Pilot Study
The purpose of the study is to establish a Standard Operating Procedure (SOP) for the screening of pathologies associated with prediabetes and type 2 diabetes.
- Trial name
- NCT05314036
- Testing
- Standardized test meal
- Where
- Canada
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- SciMar Ltd.
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
Breast Pumping
Evaluation of Fluid-Filled Expression Core Technology Study - I
A functional model of a fluid-filled, smaller dead volume breast pump has been developed in order to more closely mimic the breastfeeding infant.
- Trial name
- Effect-1 (NCT03921918)
- Testing
- Breast Pump
- Where
- Switzerland
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Medela AG
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)
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
Breastfeeding Mothers
Atlas of Human Milk Nutrients
The main objective of this clinical trial is to collect human milk samples from 0 to 4 months after delivery in order to characterize human milk components. The secondary objectives of this study are: 1.
- Trial name
- NCT01894893
- Where
- 13 sites in France, Italy and 5 more
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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
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
Breast Pumping
Clinical Validation of the Ameda Pearl - An Electric, Hospital Grade, Multi-User Breast Pump
This study introduces a new Ameda electric multi-user, hospital-grade breast pump, the Ameda Pearl, to mothers who choose to exclusively breast pump until their infants are able to breastfeed.
- Trial name
- NCT05297799
- Testing
- Ameda Pearl breast pump
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Ameda, Inc.
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
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
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
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
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)
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