Clinical trials: Breast Milk
Food Allergy
ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults
The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.
- Trial name
- NCT04856865
- Testing
- Low dose ADP101, High dose ADP101
- Where
- 15 sites in United States
- Volunteers
- 73 people
- Sponsor
- Alladapt Immunotherapeutics, Inc.
Preterm Delivery, Inadequate Milk Production
Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
Induction and support of lactation in women with preterm delivery and inadequate milk production.
- Trial name
- MERMAID (NCT02545127)
- Testing
- Merotocin
- Where
- 10 sites in United States
- Volunteers
- 4 people
- Sponsor
- Ferring Pharmaceuticals
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.
Venous Thromboembolism, Atopic Dermatitis
The Incidence of Venous Thromboembolism in Atopic Dermatitis
This study aims to investigate the incidence of venous thromboembolism in people who are diagnosed with atopic dermatitis.
- Conditions
- Venous Thromboembolism, Atopic Dermatitis, Pulmonary Embolism, Deep Vein Thrombosis
- Trial name
- NCT04969653
- Testing
- Exposure of venous thromboembolism
- Where
- United Kingdom
- Volunteers
- 754,745 people
- Sponsor
- Momentum Data
Healthy Volunteers
A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants
The purpose of this study is to evaluate Deucravacitinib concentrations in the breast milk and plasma of healthy lactating female participants.
- Trial name
- NCT06476834
- Testing
- Deucravacitinib
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Colitis, Ulcerative, Crohn's Disease
Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease
The purpose of this study is to assess the concentration of vedolizumab in breast milk of lactating women with active ulcerative colitis (UC) or Crohn's disease (CD) who are receiving vedolizumab therapeutically.
- Trial name
- NCT02559713
- Testing
- Vedolizumab
- Where
- 7 sites in United States
- Volunteers
- 11 people
- Sponsor
- Takeda
Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
The primary objectives of this study are to assess whether there is transfer of Certolizumab Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing regimen of CZP by evaluating the concentration…
- Conditions
- Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis, Crohn's Disease
- Trial name
- CRADLE (NCT02154425)
- Testing
- Breast milk sampling, Certolizumab Pegol
- Where
- 6 sites in United States, Netherlands and 1 more
- Volunteers
- 17 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Neonatal Abstinence Syndrome
Donor Human Milk in Neonatal Abstinence Syndrome
This study is designed to develop pilot data on the acceptability and benefit of donor human milk for infants undergoing pharmacologic treatment for NAS.
- Trial name
- DHM&NAS (NCT02182973)
- Testing
- donor human milk
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neolac Inc dba Medolac Laboratories
Growth and Development
Investigation of Iron Uptake From Micronutrient Fortified Powder Versus From Tailored Control in Milk
The present study supplements iron as part of multiple micro-nutrient supplementation to demonstrate that intake of a micronutrient fortified powder in milk helps increase the uptake of key micronutrients like iron due to unique…
- Trial name
- NCT02254460
- Testing
- Test, Control
- Where
- India
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Participants
A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women
The purpose of the study is to assess the concentration of rozanolixizumab in mature breast milk of healthy study participants following administration of a single dose of rozanolixizumab
- Trial name
- NCT06720714
- Testing
- Rozanolixizumab
- Where
- 2 sites in United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma SRL
Food Allergy
Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy
The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after 12 months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated cow's milk allergic children and to assess the…
- Trial name
- MILES (NCT02223182)
- Testing
- Viaskin Milk 150 mcg, Viaskin Milk 300 mcg, Viaskin Milk 500 mcg
- Where
- 17 sites in United States, Canada
- Volunteers
- 198 people
- Sponsor
- DBV Technologies
Cow's Milk Allergy
Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy
This is a prospective, controlled, multi-country study to verifying the hypoallergenicity of the new amino acid-based formula in infants and children aged< 12 years with documented cow's milk protein allergy (CMPA).
- Trial name
- RAF (NCT02414243)
- Testing
- New Amino Acid formula, Commercially available Amino Acid Formula
- Where
- Italy
- Volunteers
- 41 people
- Sponsor
- Laboratorios Ordesa
Healthy Lactating Women
Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) in the Breast Milk of Healthy Lactating Women
This study is designed to characterize the excretion of bempedoic acid or bempedoic acid and ezetimibe into mature breast milk of healthy lactating women and assess the exposure to the breast fed infant by estimating the daily…
- Trial name
- NCT06021951
- Testing
- Bempedoic Acid 180 MG Oral Tablet, Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Esperion Therapeutics, Inc.
Erosive Esophagitis, Heartburn
A Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once Daily or Vonoprazan 20 mg Twice Daily
The primary objective is to determine the pharmacokinetics (PK) of vonoprazan in breast milk of healthy lactating women who have received vonoprazan administered once daily or vonoprazan 20 mg administered twice daily for 4…
- Conditions
- Erosive Esophagitis, Heartburn, Symptomatic Nonerosive Gasroesophageal Reflux Disease, Helicobacter Pylori Infection
- Trial name
- NCT06391177
- Testing
- Vonoprazan
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Phathom Pharmaceuticals, Inc.
Healthy Lactating Women
Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women
This is an open label, single treatment, multiple doses lactation study of SPN-812 in healthy lactating women. The study is designed to assess the excretion of viloxazine and its major metabolite 5-HVLX-gluc into breast milk…
- Trial name
- SPN-812 (NCT06259331)
- Testing
- SPN-812 (600mg, QD)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Supernus Pharmaceuticals, Inc.
Amatoxin Poisoning, Amanita Poisoning
Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
Legalon® SIL will be administered to patients with amatoxin poisoning diagnosed by history, gastrointestinal symptoms, elevated liver enzymes, and/or diagnostic assay (should one become available).
- Conditions
- Amatoxin Poisoning, Amanita Poisoning, Mushroom Poisoning, Liver Failure
- Trial name
- NCT00915681
- Testing
- Silibinin
- Where
- 2 sites in United States
- Volunteers
- 148 people
- Sponsor
- Mylan Specialty, LP
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
No Disease
Efficacy of Polyphenols From Milk and Dark Chocolate
Dark chocolate is one of the richest sources of polyphenols though it has been hypothesised that the bioavailability and therefore probably the bioefficacy of epicatechin from milk chocolate was reduced compared to dark.
- Trial name
- NCT00513344
- Testing
- Dark Chocolate, Milk Chocolate, Control (polyphenol-free) "Chocolate"
- Where
- Switzerland
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)