Clinical trials: Lactation
Multiple Sclerosis
Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis
This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS).
- Trial name
- KATHAROS (NCT06444113)
- Testing
- Ofatunumab
- Where
- 15 sites in United States, Germany and 3 more
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Breast Feeding, Constipation
A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically
The purpose of this study is to determine the amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk after multiple, once daily doses of linaclotide (72 μg, 145 μg, or 290 μg) in lactating women…
- Conditions
- Breast Feeding, Constipation, Irritable Bowel Syndrome
- Trial name
- LIN-PK-01 (NCT02220348)
- Testing
- linaclotide
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Forest Laboratories
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
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
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
Thrombocytopaenia
Milk-only Lactation Study for Patients on Eltrombopag
This is a Phase IV study to evaluate eltrombopag concentrations in breast milk of nursing mothers taking marketed eltrombopag (PROMACTA®).
- Trial name
- NCT01055600
- Testing
- eltrombopag
- Where
- United States
- Sponsor
- GlaxoSmithKline
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
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 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
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
Inflammatory Bowel Disease
A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease
Inflammatory bowel disease (IBD) is a chronic inflammatory disease that requires lifelong treatment. This study will asses the concentrations of risankizumab in the breast milk of lactating women with IBD Risankizumab is an…
- Trial name
- NCT06346288
- Testing
- Breast Milk Sampling, Risankizumab
- Where
- 3 sites in United States, Israel
- Volunteers
- 10 people
- Sponsor
- AbbVie
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 Induced
Supplementation of Galatonol 300 mg / Striatin 30 mg in Postpartum Lactating Mothers
This is a randomized, double-blind, and placebo-controlled study involving mothers as the participant and participant's babies evaluating the effect of a 15-day-supplementation with a product containing extracts derived from a…
- Trial name
- NCT06558071
- Testing
- Galatonol 300 mg/Striatin 30 mg
- Where
- 10 sites in Indonesia
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Breastmilk Collection
Impact of Breast Milk on the Infectivity and Transmission of Different Viruses "BREASTMILKVIR"
Exclusive breastfeeding during the first six months of life and continued breastfeeding for at least 24 months constitute the optimal feeding method for infants and young children.
- Trial name
- BREASTMILKVIR (NCT06738563)
- Testing
- Collection breast milk
- Where
- France
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
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)
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
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
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.
Hypoparathyroidism
A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding
The purpose of this registry study is to collect both prospective and retrospective data in women exposed to palopegteriparatide during pregnancy to assess risk of pregnancy and maternal complications, and adverse effects on the…
- Trial name
- NCT07345494
- Testing
- Palopegteriparatide
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Ascendis Pharma A/S