108 Clinical Trials for Various Conditions
The purpose of this study is to unveil the mechanistic benefits of a bout of postpartum maternal exercise on infant health that are provided by breastmilk.
This study compares the iron levels in very preterm infants receiving donor breast (DBM) milk to very preterm infants receiving maternal breast milk (MBM).
The goal of this prospective cohort pilot study is to learn about food allergens being passed on in breast milk to breast feeding infants. The main question\[s\] it aims to answer are: * Will major allergens for milk, egg, and peanut be passed on to infants in breast milk? * Will the infants become sensitized to and develop an allergy to the food allergens found in breast milk? * Will early introduction interventions prevent the development of these food allergies? Participants will * provide breast milk sample (s) for testing for food allergens * Infants will be tested for sensitization via skin prick and blood testing * Infants will be challenge with suspected foods to determine allergy and undergo early introduction procedures
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
The purpose of this study is to evaluate Deucravacitinib concentrations in the breast milk and plasma of healthy lactating female participants.
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. This would allow to see if there are any possible risk to infants from medicines during breast-feeding. The study is seeking for about 12 healthy breast-feeding females who are: * 18 to 55 years of age. * actively breast-feeding or producing breast milk. * at least 2 weeks post-partum and not pregnant at present. Participants will not be allowed to breast-feed their infant from the evening of the day before to the first dose till 48 hours (2 days) after the dose. Eligible participants will check into the clinical research unit (CRU) on Day -1. Participants will receive the zavegepant dose sprayed into the nose at the CRU on Day 1. The participants will stay at the CRU until the morning of Day 2. There will be collections of breast milk and plasma over 24 hours. Participants will be sent from the CRU on Day 2 and may begin to breastfeed their infant 48 hours (2 days) after the dose. A safety follow-up call will be done at about 28 to 35 days from the day the first dose of study medicine was given.
This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum.
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 consecutive days.
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 approved drug for adults with plaque psoriasis, psoriatic arthritis, and Crohn's Disease. This is an open-label milk-only study lactation study to evaluate the presence of risankizumab in the milk of lactating women. Approximately 10 adult lactating women with IBD will be enrolled from approximately 3 sites in Israel and or the United States. Participants will receive risakizumab maintenance therapy every 8 weeks postpartum prior to start of participation in this study. The study duration is approximately 7 months. Participants will attend regular visits during the study at a hospital or clinic. The participants will also be completing questionnaires and will have medical assessments, checking for side effects.
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 following repeated administration of SPN-812 600 mg, QD. This study is comprised of Screening, Inpatient Admission, Treatment Period and End of Study (EOS). The total duration of the study is up to 32 days including Screening up to 28 days and 4 days of Treatment Period. Subjects will remain in the inpatient unit for 5 days, including the day of admission to the inpatient unit (Day -1), 3 days of dosing SM (Days 1-3), and the day of discharge (Day 4).
This is an open label study to investigate PK of tenapanor and AZ13792925 in breast milk of lactating female subjects.
Infants The purpose of this study is to measure breastmilk's vitamin D sulfate nutritional value in infant's saliva and digesta (gut). Breastfeeding Mothers The purpose of this study is to measure Vitamin D sulfates in freshly expressed breastmilk samples before and after 28 days of Vitamin D supplementation in lactating mothers.
The primary objective of the lactation study is to characterize the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who receive BRIUMVI™ therapeutically for the treatment of relapsing forms of multiple sclerosis (RMS).
This is a prospective, non-randomized, phase I study design evaluating the in vivo activities and expression of OCT1 and BCRP in mammary gland of lactating women at three time points postpartum.
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 infant dosage and the relative infant dose (RID) of bempedoic acid or bempedoic acid and ezetimibe in breast milk after 6 consecutive daily doses of bempedoic acid or bempedoic acid/ezetimibe FCDP.
A study to measure daridorexant in breast milk of healthy lactating women
This clinical lactation study is to provide information regarding the PK and amount of OLZ/SAM in breast milk and estimated infant exposure.
This project aims to measure the widely consumed low-calorie sweeteners (LCS) sucralose and acesulfame-potassium, in maternal breast milk and plasma at pre-specified timepoints over 72 hours and in a single sample of infants' plasma. Sucralose and acesulfame-potassium concentrations will be measured using liquid chromatography-mass spectrometry (LC-MS). The data generated will inform the design of larger, longer-term, prospective studies needed to investigate clinically-relevant consequences of early life LCS exposure in humans.
This is a trial to assess the effects of the Trulacta supplement on biological age, sleep quality, immune system and wellness markers.
The benefits of breastfeeding and human milk consumption by infants has been clearly demonstrated. Benefits to the infant include reduction of infant and childhood diseases and allergies. Benefits to the woman include more rapid return to pre-pregnancy weight and reduced risk of health problems such as cardiovascular disease and diabetes in the future. Many women take medications as part of their standard of care and for multiple medical reasons in the postpartum period, when breastfeeding occurs. This creates a need for information about the transfer of drugs taken by a woman into breast milk, and ultimately, to the infant. Unfortunately, there are limited pharmacokinetic (PK) data on many of the medications commonly taken by lactating women. Additionally, there are little data on how the PK of drugs are impacted by lactation, and how this may vary from woman to woman or with time throughout lactation. Uptake of drugs into breast milk can vary due to a number of factors, including drug lipophilicity; molecular weight; drug half-life; active transport in breast epithelial cells; protein binding in milk and plasma; and lipid composition of breast milk. In silico and animal models can provide some information on transfer of drugs into breast milk, however, there are large gaps remaining in our knowledge of drug transfer into human milk. This information is crucial to better inform providers and patients about the transfer of those drugs to human breast milk. The purpose of this study is to characterize the PK of specific drugs of interest taken by lactating women as part of their standard of care. The drugs of interest (DOI) will be based on medical relevance and availability throughout the course of the study. The purpose of this study is to characterize the PK of medications taken by lactating women as part of their standard of care.
The purpose of study JZP110-401 is to evaluate solriamfetol pharmacokinetics (PK) in the breast milk and plasma of healthy postpartum women following the administration of the drug. The study also aims to estimate the potential daily solriamfetol dose received by the infant from the breast milk of the nursing mother. The safety and tolerability of single oral doses of solriamfetol will also be assessed.
Skin breaking procedure through an automated heel lancet for blood draws is a common painful procedure in the Neonatal Intensive care unit (NICU). Recurrent pain in preterm neonates is associated with long-term complications. The primary objective of the study is to compare pain scores between two groups (24% sucrose and breast milk) during blood draw using an automated heel lancet in preterm neonates. The investigator conducted a prospective randomized controlled trial in preterm neonates, to compare the pain scores in infants receiving either breast milk or sucrose. Premature Infant pain profile- Revised pain profile is used to assign pain scores. The primary outcome measure is the comparison of pain scores between the two groups.
The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is feasible.
This study will investigate the effects of breastfeeding and breastmilk composition on infant gut microbiome development as well as obesity and cognitive outcomes. Breast milk contains certain natural sugars that can promote the growth of 'good' bacteria in the intestines and reduce the growth of harmful bacteria. The purpose of this study is to look at the effects of these natural sugars in breast milk on the infant's bacteria and the impact of this on development of obesity and cognitive outcomes by 2 years of age with plans for longer term follow up contingent upon funding.
This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants. The purpose of the study is to determine if there is a benefit to target fortifying donor breast milk in the preterm population. The investigators hypothesize that infants receiving targeted fortification of donor breast milk will have improved growth compared to infants receiving standard fortification of donor breast milk.
Quantification of Ketamine in Breast Milk at 3 hour Intervals up to 30 hours-- obtained from lactating women who receive 2 different Intramuscular injections of ketamine on two separate days at least 5 days apart.
This clinical trial will compare stool and oral microbiome composition between infants fed breast milk or one of two infant formulas for a 60 day feeding period.
This study evaluates the effectiveness of individualized human milk fortification for very low birth weight (\<1500 g) babies in the NICU (Neonatal Intensive Care Unit) to optimize their growth. Breast milk analysis will occur on a weekly basis using the Miris Human Milk Analyzer. In the Control group, participants will receive standard TPN (total parenteral nutrition) and lipids and breast milk fortification according to MetroHealth's NICU guidelines. The Intervention group will receive TPN and lipids optimized depending on the results of breast milk analysis, followed by additional individualized fortification using additional microlipids and/or liquid protein to achieve the goal of 4g protein/kg/day and 100-130 kcal/kg/day.
This is an observational cohort study of 221 breast-feeding mother-infant dyads delivered at term. The goal of the study is to investigate whether levels of immune-related microRNAs (miRNAs) in maternal breast milk (MBM) influence child atopy risk in the first 12 months, defined as atopic dermatitis, wheezing, or food allergy. Infant exposure to individual miRNA components will be quantified at 0, 4, and 16-weeks after delivery using high throughput RNA sequencing of MBM samples and detailed dietary logs employing the Infant Feeding Practices (IFP) survey. The relationship of individual miRNA exposures (parts per million) and presence/absence of atopy in the 48 weeks after delivery will be assessed, while controlling for environmental exposures (National Survey of Lead hazards and Allergens in Housing), maternal diet, and genetic predisposition. Potential transfer of MBM miRNAs to the infant oropharynx and subsequent impact on immune reactivity will also be explored through RNA sequencing of infant saliva and quantification of cytokine profiles.
This study is a nutrition research study designed to look at how healthy meals can influence the content of breast milk. Moms will be provided with meals that follow a Mediterranean diet pattern for 4 weeks. The goal of the study is to see if breast milk content changes over the 4 week period. The infants of the moms will also be included in the study to measure any changes in growth.