Clinical trials: Plant-based Milk
Allergy;Food
A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula
Cow's Milk Allergy (CMA) affects between 2-3% of young children but its severity varies between regions/countries. While the long-term prognosis for CMA is good, with the majority (80-90%) of children outgrowing their allergy by…
- Trial name
- CHARM (NCT04519827)
- Testing
- New Rice-based hydrolysate, Amino Acid-based infant formula
- Where
- 4 sites in Italy, Spain
- Volunteers
- 39 people
- Sponsor
- Dr. Schär AG / SPA
Body Weight
Growth and Tolerance of Cow Milk-Based Infant Formulas
This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant formulas in healthy, term infants.
- Trial name
- NCT01122654
- Where
- 24 sites in United States
- Volunteers
- 405 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Gastrointestinal Disorder, Functional, Regurgitation, Gastric
Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) Study
To compare the frequency of regurgitation and other digestive outcomes between infants who receive an infant formula based on whole goat milk and an infant formula based on cow milk proteins during the transition period from…
- Conditions
- Gastrointestinal Disorder, Functional, Regurgitation, Gastric, Colic, Infantile, Constipation - Functional
- Trial name
- TIGER (NCT05363553)
- Testing
- Infant formula based on whole goat milk, infant formula based on cow milk proteins
- Where
- Thailand
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Dairy Goat Co-operative (N.Z.) Limited
Glycemic, Insulinemic, Subjective Appetite Responses
Glycemic and Insulinemic Response to Oats Soaked Overnight in Milk Compared to Cream of Rice in Healthy Subjects
One objective of this study is to examine the blood glucose and serum insulin responses over 2hr elicited by oats soaked overnight in milk compared to Cream of Rice soaked overnight in milk and compared to Cream of Rice cooked in…
- Trial name
- NCT03150251
- Testing
- Cereal - oats, Cereal - cream of rice
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- PepsiCo Global R&D
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
Cow's Milk Allergy
Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula
Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order.
- Trial name
- NCT02450643
- Testing
- Test extensively hydrolyzed formula, Control extensively hydrolyzed formula
- Where
- 8 sites in United States
- Volunteers
- 83 people
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy
A Study of Doravirine/Islatravir in Healthy Lactating Females (MK-8591A-061)
The goal of this study is to learn what happens to doravirine (DOR) and islatravir (ISL) in a healthy lactating female's body over time. Researchers want to learn if DOR and ISL are in breast milk.
- Trial name
- NCT07086079
- Testing
- DOR/ISL
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Malnutrition; Mild, Iron-deficiency Anemia
The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers
It is well known than an important part of Nigerian children from the lower social economic class have nutrient deficiencies. Fortified products, such as growing up milks (GUM), may play an important role in reducing the risk and…
- Conditions
- Malnutrition; Mild, Iron-deficiency Anemia, Nutritional Stunting, Nutritional Wasting
- Trial name
- GaGA (NCT03411590)
- Testing
- Fortified milk Powder
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- FrieslandCampina WAMCO Nigeria PLC
Mildly Hypercholesterolemic Subjects
Effects of Fermented Milk Product Enriched With Plant Sterols and Policosanols in Mild Hypercholesterolaemic Adults
The objective of this study is to investigate the effect of consumption of a low-fat, no added sugar, dairy fermented product enriched with plant sterols and policosanols at two doses, on LDL-cholesterol concentration in…
- Trial name
- NCT01571882
- Testing
- 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 10 mg of policosanols per unit, 2- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 20 mg of policosanols per unit, 3- Low fat drinkable fermented dairy product with 1.6g of plant sterol (as free equivalent) but without policosanols (Active control)
- Where
- United Kingdom
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Danone Global Research & Innovation Center
Healthy
Toddler Milk Intervention Trial
To assess growth of children (enrolled between 11.5 and 13.5 months) fed with two iso-energetic, young-child formulas with different protein content during the second year of life
- Trial name
- NCT02907502
- Testing
- Young-child formula with low protein content, Young-child formula with protein content similar to that of cow's milk
- Where
- 2 sites in Germany, Spain
- Volunteers
- 1,618 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Gastrointestinal Microbiome
Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas
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.
- Trial name
- NCT04059666
- Testing
- Investigational, Control
- Where
- 5 sites in United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Cow Milk Allergy
Growth of Infants With Cow's Milk Allergy Fed an Amino Acid-based Formula Containing Two Human Milk Oligosaccharides
The main aim of this study is to provide longitudinal growth data in infants with moderate-to-severe cow's milk allergy fed an amino acid-based formula with two added human milk oligosaccharides.
- Trial name
- PLATYPUS (NCT03661736)
- Testing
- Food for Specific Medical Purpose
- Where
- Australia
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Prevention of Growth Restriction
Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants
The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo.
- Trial name
- LAIF (NCT01413581)
- Testing
- rhBSSL (recombinant human bile-salt-stimulated lipase)
- Where
- 49 sites in Belgium, Czechia and 8 more
- Volunteers
- 415 people
- Sponsor
- Swedish Orphan Biovitrum
Food Allergy
Open-label Extension Study of ADP101
This is an open-label, safety extension study for participants who participated in the Harmony study (protocol ADP101-MA-01).
- Trial name
- NCT05243719
- Testing
- ADP101
- Where
- 14 sites in United States
- Volunteers
- 45 people
- Sponsor
- Alladapt Immunotherapeutics, Inc.
Breast Pain
L.Fermentum CECT5716 in Treatment of Breast Pain
The main objective of this intervention study is to evaluate the efficacy of Lactobacillus fermentum CECT5716 to reduce the presence in the milk of genera Staphylococcus and Streptococcus as risk factors for mastitis in women…
- Trial name
- NCT02093338
- Testing
- Lactobacillus fermentum CECT5716
- Where
- Spain
- Volunteers
- 127 people
- Sponsor
- Biosearch S.A.
Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn
Infant Formula Feeding and Necrotizing Enterocolitis in Newborns
Necrotizing enterocolitis (NEC) is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality.
- Conditions
- Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Cows Milk Allergy
- Trial name
- NCT05121753
- Testing
- Survey investigating Infant formula feeding in newborns
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Neuroganics LLC
Healthy
A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women
The main purpose of this study is to assess the concentrations of nipocalimab (pharmacokinetics [PK]) in the breast milk after administration of a single dose of nipocalimab into the vein, in healthy lactating women.
- Trial name
- NCT07669077
- Testing
- Nipocalimab, Breast Milk Sampling
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Bioavailability of Amino Acids
Amino Acids in the Blood After Eating Yoghurt and Milk Proteins
Participants will visit the study site twice in a fasting state. Participants asked to consume one of the two study products in a random order. Participants will consume one serving of the study product (T = 0 minutes).
- Trial name
- NutraFerm2 (NCT07243730)
- Testing
- Full fat yogurt (fermented), Generic full fat pasteurized milk (non-fermented)
- Where
- Netherlands
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Protein Allergy, Cow's Milk Protein Hypersensitivity
Efficacy of a New Thickened Extensively Hydrolyzed Formula
Cow Milk Allergy (CMA) occurs in 2 to 5 % of all infants. Reflux, regurgitation and vomiting are well recognised symptoms of CMA. The recommended treatment of CMA is an extensive hydrolysate.
- Trial name
- ALLAR (NCT01985607)
- Testing
- new extensively hydrolysed formula, Extensively hydrolysed formula
- Where
- 5 sites in Belgium, Greece and 3 more
- Volunteers
- 72 people
- Sponsor
- United Pharmaceuticals
Ig-E Mediated Food Allergy
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy: This is a Phase 2b randomized, double-blind, placebo-controlled clinical trial evaluating RPT904, a next-generation anti-IgE monoclonal…
- Trial name
- NCT07220811
- Testing
- RPT904
- Where
- 37 sites in United States, Australia and 1 more
- Volunteers
- 100 people
- Sponsor
- RAPT Therapeutics, Inc., a member of the GSK plc group of companies