Clinical trials: Lactation
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)
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
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.
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
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
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)
Infant Term Birth
Acceptability and Gastrointestinal Tolerance of a High-Sn-2 Infant Formula
The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition, stool characteristics and gastrointestinal (GI) Tolerance.
- Trial name
- NCT02598817
- Testing
- Standard Infant Formula
- Where
- 5 sites in Saudi Arabia, United Arab Emirates
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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.
Breast Feeding
A Post Breastfeeding Follow-Up Study
The purpose of this clinical study which is to evaluate the benefits of lactation support intervention, in conjunction with maternal nutritional supplementation during the last trimester to 12 weeks postpartum in comparison to…
- Trial name
- NCT02913638
- Where
- 4 sites in Vietnam
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Lactation
Evaluation of the Functionality of a Fluid Filled Single Breast Pump
This study is an early (during the product development process) feasibility study. It shall evaluate the device design concept with respect to device functionality of a new fluid filled breast pump in a small number of subjects.
- Trial name
- C88 (NCT02542527)
- Testing
- Fluid filled breast pump
- Where
- Switzerland
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Medela AG
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
Breast Feeding
Human Milk Composition in Indian Mothers
Nutritional profile of mother's milk is influenced by various factors including environmental, dietary and nutritional status of the mother.
- Trial name
- NCT03061929
- Where
- 8 sites in India
- Volunteers
- 248 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
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
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.
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, 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 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.
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, Education, Nursing
Effect of a Newborn Simulator's Fidelity on Nursing Students' Level of Engagement in a Clinical Lactation Encounter
Nursing students (N=32) will be randomized to begin period 1 in either a high-fidelity or low-fidelity simulated experience with a mock patient wearing a breast model and holding a newborn simulator and then cross over in period…
- Trial name
- NCT05316909
- Testing
- Breastfeeding Simulation
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- LiquidGoldConcept
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