Clinical trials: Tolerance
IgE-Mediated Cow Milk Allergy
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
The goal of this clinical trial is to see if a new formula based on hydrolysed rice proteins (Rice formula) is well tolerated by infants and young children with cow's milk allergy.
- Trial name
- NCT07197814
- Testing
- Rice formula (New formula based on hydrolysed rice proteins)
- Where
- Italy
- Volunteers
- 29 people
- Sponsor
- Health and Happiness Research Limited
Atopic Diathesis, Eczema-prone Skin
Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 5 Days of Use on Subjects With Atopic Dermatitis
The aim of this study is to compare the efficacy and tolerability and of a cosmetic product to one that is already available on the market (benchmark product).
- Trial name
- NCT05807113
- Testing
- Atopi intensive care BNO 3731, Benchmark product
- Where
- Germany
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Bionorica SE
HIV Infections
A Study of Delavirdine Mesylate in Combination With Other Anti-HIV Drugs in HIV-Infected Children and Babies
The purpose of this study is to see if it is safe and effective to give delavirdine mesylate (Rescriptor) plus two nucleoside reverse transcriptase inhibitors (NRTIs) to HIV-infected children and babies.
- Trial name
- NCT00002210
- Testing
- Delavirdine mesylate
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Pharmacia and Upjohn
Tyrosinemia, AKU
Evaluation of TYR Sphere in France
10 participants aged 3 years and over with tyrosinaemia or alkaptonuria will be prescribed Tyr sphere following an assessment of their individual needs by their dietitian.
- Trial name
- TYR sphere Fra (NCT04761588)
- Testing
- Tyr sphere
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Vitaflo International, Ltd
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 Disease, Inflammatory Bowel Disease (IBD)
Elemental 028 Extra Case Studies
Elemental 028 Extra is a nutritionally complete ACBS approved amino acid-based (elemental) feed designed to provide adequate daily amounts of both macronutrients and micronutrients when used as a sole source of nutrition and to…
- Conditions
- Gastrointestinal Disease, Inflammatory Bowel Disease (IBD), Short Bowel, Malabsorption
- Trial name
- E028E (NCT06877923)
- Testing
- Elemental 028 Extra
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Nutricia UK Ltd
Burn Injuries
Mepilex Ag Versus Silver Sulfadiazine in Children and Adults With Burn Injuries.
The purpose is to compare time to healing using absorbent foam silver dressing (Mepilex Ag) compared to a silver sulfadiazine (SSD) 1% cream in the treatment of partial thickness burn injuries.284 in-patients in 8-12 centres in…
- Trial name
- NCT01439074
- Testing
- Mepilex Ag, Silver Sulphadiazine Ag cream
- Where
- 9 sites in China
- Volunteers
- 162 people
- Sponsor
- Molnlycke Health Care AB
Subjects in Need of a Human Milk Fortifier (HMF), Growth
Renoir: A Randomised, Double-blind, Controlled Trial to Evaluate the Effects of a New Human Milk Fortifier on Growth and Tolerance in Preterm Infants.
Preterm birth (birth before start of the 37th week of gestation) is a major determinant of neonatal morbidity and mortality and has long-term adverse consequences for health and neurodevelopment.
- Conditions
- Subjects in Need of a Human Milk Fortifier (HMF), Growth, Tolerance, Safety
- Trial name
- Renoir (NCT03315221)
- Testing
- Test product, Control product
- Where
- 15 sites in France, Germany and 2 more
- Volunteers
- 207 people
- Sponsor
- Nutricia Research
Enteral Nutrition
Study to Evaluate the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG)
This is a Multicenter, Open-label, Single-arm study evaluating the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG) in the Nutritional Management of Tube-fed Children Aged 1-4…
- Trial name
- NCT04516213
- Testing
- Enteral Formula With (PHGG)
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Société des Produits Nestlé (SPN)
Cow Milk Protein Allergy, FPIES
Tolerance and Growth Outcomes of an Extensively Hydrolysed Anti-regurgitation Casein-based Formula in Infants With Cow's Milk Protein Allergy
This study is designed as multicentric, interventional, with two successive randomised, double-blind, crossovers. The aim of the study is to demonstrate the tolerance of an extensively hydrolysed anti-regurgitation casein-based…
- Trial name
- PANDA (NCT07592182)
- Testing
- Oral Food Challenge V2, Product administration between V4 and V5, Oral Food Challenge V3
- Volunteers
- 55 people
- Sponsor
- Lactalis
Tolerance
Safety of Lactobacillus Fermentum in Newborn Infants
In the last years manipulation of intestinal microbiota with probiotics has gained an increasing interest, specially in infant nutrition since recent studies has demonstrated the presence of probiotics in human milk.
- Trial name
- NCT01346644
- Testing
- Infant formula
- Where
- Spain
- Volunteers
- 137 people
- Sponsor
- Puleva Biotech
Growth and Tolerance
Growth of Infants Fed Hydrolysate Formulas
Effects on weight and weight gain will be monitored in healthy term infants fed assigned infant formulas.
- Trial name
- NCT02006992
- Testing
- RTF Infant Formula, Powder Infant Formula
- Where
- 8 sites in United States
- Volunteers
- 195 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Infant, Newborn
Tolerance of Healthy Term Infants Fed Infant Formulas
The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.
- Trial name
- NCT00705562
- Testing
- milk protein formulas, varying carbohydrate/protein sources
- Where
- 15 sites in United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Growth
A Clinical Study to Investigate the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth, Safety and Tolerance in Healthy Term Infants
It is universally accepted that the best nutrition for a new-born infant is breast milk. Breast milk provides a complete set of nutrients to support growth and development of children in early life, including components that have…
- Trial name
- TENUTO (NCT03062761)
- Testing
- Infant Formula with prebiotics, Standard Infant Formula
- Where
- 15 sites in Finland, France and 4 more
- Volunteers
- 380 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Healthy
Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
The purpose of this study is to assess stool consistency, in combination with additional health-related parameters including gastrointestinal tolerance and health-related quality of life, in a large sample of Chinese infants.
- Trial name
- NCT01370967
- Testing
- Study formula feeding, Human milk feeding, Mixed feeding
- Where
- 24 sites in China
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Fungal Infections
A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)
The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and tolerability of oral posaconazole in immunocompromised children with neutropenia or expected neutropenia.
- Trial name
- NCT01716234
- Testing
- Posaconazole 12 mg/kg/day BID, Posaconazole 18 mg/kg/day BID, Posaconazole 18 mg/kg/day TID
- Volunteers
- 142 people
- Sponsor
- Merck Sharp & Dohme LLC
Bipolar Disorder
Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents
Main objective: To evaluate the clinical and physiological tolerance of sodium divalproate in manic, mixed or hypomanic episodes of bipolar disorder in adolescents treated for 6 months.
- Trial name
- ADOKOT (NCT00271258)
- Testing
- SODIUM DIVALPROATE
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Sanofi
Infant Term Birth
Acceptability and Gastrointestinal Tolerance of a High-Sn-2 Infant Formula
The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition, stool characteristics and gastrointestinal (GI) Tolerance.
- Trial name
- NCT02598817
- Testing
- Standard Infant Formula
- Where
- 5 sites in Saudi Arabia, United Arab Emirates
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Enteral Nutrition
Enteral Formula Tolerance in Pediatric Patients
The purpose of this prospective study seeks to assess ability to achieve enteral feeding goals with standard polymeric enteral formula in a stable, pediatric tube-fed population.
- Trial name
- NCT02779335
- Testing
- Enteral Formula
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Société des Produits Nestlé (SPN)
Acne Vulgaris
A Study to Evaluate the Effectiveness and Tolerance of Two Acne Treatments on Subjects With Mild to Moderate Acne.
This study will compare two different acne treatments for the treatment of acne. Half of the participants will receive two marketed acne products (cleanser and leave-on topical treatment), while the other half of the participants…
- Trial name
- TIGER (NCT02698436)
- Testing
- Acne Mask, 2.5% Benzoyl Peroxide Treatment
- Where
- 2 sites in United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide