Clinical trials: Plant-based Milk
Excessive Intestinal Gas Production
Evaluation of a 28-day Fermented Milk Product Consumption Twice Daily as Compared to a Non-fermented Milk Product on Intestinal Gas Production in Healthy Subjects High Dihydrogen Producers
The purpose of this study is to assess the effect of a 28-day fermented milk product consumption twice daily on intestinal gas production of dihydrogen (H2) and methane (CH4) in healthy subjects high H2 producers.
- Trial name
- BREEZE (NCT03015441)
- Testing
- Milk product fermented by lactic bacteria or not fermented
- Where
- Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Danone Global Research & Innovation Center
Healthy Infants
Second Generation Human Milk Oligosaccharides Blend Study
The aim of this trial is to show that infants fed these new formulas, containing a blend of 5 Human Milk Oligosaccharides (HMOs), allow for growth in line with infants fed formulas without HMOs.
- Trial name
- NCT03722550
- Testing
- Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk Oligosaccharides, Breast-feeding, Standard Starter Infant Formula, Follow-up Formula, and Growing-up Milk
- Where
- 34 sites in Bulgaria, Hungary and 1 more
- Volunteers
- 789 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Irritable Bowel Syndrome
Assessment of the Symbiotic Fermented Milk in Patients With Irritable Bowel Syndrome
This study evaluates the effect of a symbiotic fermented milk on health-related quality of life and irritable bowel syndrome (IBS) symptoms in patients with constipation-predominant IBS.
- Trial name
- NCT02391220
- Testing
- LCA symbiotic fermented milk, heat-treated fermented milk
- Volunteers
- 76 people
- Sponsor
- Clinres Farmacija d.o.o.
Breast Milk
Human Milk Profiles and Dietary Intake of Chinese Lactating Mothers During Early Lactation Period in Shanghai
This study aims to investigate breast milk composition and dietary habits of Chinese lactating mothers. Further understanding of the composition of human milk will help to understand the nutritional needs of mothers and their…
- Trial name
- MuRu (NCT02070562)
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Dumex Baby Food Co., Ltd.
Healthy Diet
Detection of Gut Metabolites in Mother's Milk Following Juice Intake
The goal of the biological sample collection is to assess the presence of gut metabolites in human breast milk (BM) samples obtained prospectively from healthy lactating mothers and after consumption of fruit juice.
- Trial name
- NCT04596254
- Testing
- Pomegranate Juice
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Amazentis SA
Replacement Therapy in Preterm Infants
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.
- Trial name
- NCT00658905
- Testing
- rhBSSL
- Where
- 6 sites in Italy
- Volunteers
- 33 people
- Sponsor
- Swedish Orphan Biovitrum
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
Cow Milk Allergy
Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula
This is a single arm, open label, multicenter intervention trial to evaluate growth parameters, cow's milk related symptoms, gastrointestinal tolerance and safety in infants with cow's milk allergy receiving a hydrolyzed protein…
- Trial name
- STORY (NCT05618704)
- Testing
- Hydrolyzed protein infant formula
- Where
- Poland
- Volunteers
- 69 people
- Sponsor
- Nutricia Research
Growth, Tolerance
Human Milk Oligosaccharides (HMOs) Post-market Study on Infants
Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT).
- Conditions
- Growth, Tolerance, Adverse Event, Disorder of Intestine
- Trial name
- NEHMO (NCT04055363)
- Testing
- HMO-supplemented infant formula
- Where
- 6 sites in Spain
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Cow's Milk Allergy, Intolerance to Extensively Hydrolyzed Formulas
Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas
This clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.
- Conditions
- Cow's Milk Allergy, Intolerance to Extensively Hydrolyzed Formulas, Intolerance to Breast Milk
- Trial name
- NCT01470768
- Testing
- Amino Acid-based Formula with high DHA and ARA, Amino Acid-based Formula with lower DHA and ARA
- Where
- United Kingdom
- Sponsor
- Mead Johnson Nutrition
Breast Feeding, Milk, Human
A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk
The current longitudinal (max. 2-year) observational cohort study in 120 lactating mothers and their newborns will make it possible to explore human milk composition across different lactation stages, between different human milk…
- Trial name
- NCT05979532
- Where
- Netherlands
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
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
Healthy Infants
Efficacy of Two HMOs in Chinese Infants
This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier…
- Trial name
- NCT06361719
- Testing
- Experimental Group (EG), Control Group (CG)
- Where
- China
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Diabetes Mellitus, Type 2
A Research Study to See How Much Semaglutide and SNAC is in the Milk of Healthy, Breastfeeding Women Taking Semaglutide Tablets
Participants in the study, will receive the study drug once daily for 10 days in tablet form for oral (by mouth) intake. On day 1 to 5 the tablet will contain 3 mg semaglutide, and on day 6-10 the tablet will contain 7 mg…
- Trial name
- NCT04817644
- Testing
- Oral semaglutide
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Gastro-Intestinal Tolerance
Growth and Tolerance of Infants Fed Milk-Based Infant Formula
The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.
- Trial name
- NCT03967132
- Testing
- Control Infant Formula, Experimental Infant Formula, Reference Group
- Where
- 19 sites in United States
- Volunteers
- 189 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Infants
Healthy Term Infants Fed Milk-Based Formulas
This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.
- Trial name
- NCT02069522
- Testing
- Standard Milk-based Formula Containing Carotenoid, Investigational Milk-based Formula Containing Carotenoid
- Where
- 6 sites in United States
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
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
Lactation, Inflammatory Bowel Disease
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
The main purpose of this study is to assess the amount of mirikizumab in breast milk in women who are breastfeeding who are receiving stable maintenance doses of mirikizumab for an approved indication.
- Trial name
- NCT07612267
- Testing
- Mirikizumab
- Where
- 20 sites in United States, Canada and 5 more
- Volunteers
- 14 people
- Sponsor
- Eli Lilly and Company
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, 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.