Clinical trials: Gastro-Intestinal Tolerance
Gastrointestinal Tolerance
Tolerance of Healthy Term Infants Fed Infant Formulas #3
The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.
- Trial name
- NCT00977964
- Testing
- Experimental milk protein infant formula Process A, Experimental milk protein infant formula Process B, Experimental milk protein infant formula Process C
- Where
- 15 sites in United States
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Gastroesophageal Reflux
Study on the Tolerance and Efficacy of a New Anti Regurgitation Formula
The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation.
- Trial name
- SONAR (NCT02425423)
- Testing
- New thickened formula
- Where
- 3 sites in Belgium, France
- Volunteers
- 100 people
- Sponsor
- United Pharmaceuticals
PKU
Evaluation of PKU UP
PKU UP is a prospective, single-arm, open-label, 26-week acceptability study to evaluate PKU UP for the dietary management of participants with phenylketonuria (PKU).
- Trial name
- PKU UP (NCT05995717)
- Testing
- PKU UP
- Where
- 7 sites in United Kingdom
- Volunteers
- 16 people
- Sponsor
- Vitaflo International, Ltd
Healthy
Gastrointestinal Tolerance of D-allulose in Children
D-allulose, a low-calorie sugar, provides an attractive alternative to sucrose and added sugars in products. This study aimed to verify the tolerance of d-allulose in children, in doses that are Generally Recognised As Safe…
- Trial name
- NCT06063096
- Testing
- D-allulose
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Tate & Lyle
Child Nutrition Disorders
Acceptability, Gastro Intestinal Tolerance Compliance of a Paediatric Tube-feed Formula Derived From Food for Children
This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of pediatric formula for the dietary management of participants with short bowel syndrome; intractable…
- Trial name
- NCT03718195
- Testing
- Pediatric Formula
- Where
- 3 sites in United Kingdom
- Volunteers
- 19 people
- Sponsor
- Société des Produits Nestlé (SPN)
Dietary Exposure
Acceptability and Tolerance Study of Adult Tube Feed with Food with Food Derived Ingredients.
Product acceptability data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service Executive (HSE) submission for Ireland for product…
- Trial name
- NCT06102122
- Testing
- Compleat
- Where
- United Kingdom
- Volunteers
- 18 people
- Sponsor
- Société des Produits Nestlé (SPN)
Infant
Comparative Ca Absorption and Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends
The objective is to assess the comparative calcium absorption and gastrointestinal (GI) tolerance in healthy normal term infants fed two commercially available powdered milk-based formulas which contain different fat blends.
- Trial name
- NCT00941564
- Testing
- Infant Formula milk based
- Where
- Brazil
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Gastrointestinal Tolerance
Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula
The purpose of this study is to evaluate the growth and compliance of an intended use population of infants receiving an extensively hydrolyzed infant formula.
- Trial name
- NCT03597113
- Where
- 46 sites in Turkey (Türkiye)
- Volunteers
- 320 people
- Sponsor
- Abbott Nutrition
Growth
Evaluation of Safety, Growth, Tolerance and Effects on the Intestinal Fora of a New Milk for Healthy Infants
The purpose of the study is to assess growth and tolerance in new born and infant fed an experimental infant formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic.
- Trial name
- Pétunia (NCT00920166)
- Testing
- Pétunia 1, Regular formula
- Where
- 4 sites in France
- Volunteers
- 97 people
- Sponsor
- Sodilac
Gastro-Intestinal Tolerance
Formula Tolerance of Term Infants
To assess the effects of infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants
- Trial name
- NCT04915937
- Testing
- Study Infant Formula
- Where
- 12 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Nutrition Disorder, Child
Acceptability and Tolerance Study of a High Energy Peptide Based Paediatric Oral Nutritional Supplement for Children
This is an acceptability study (including gastrointestinal tolerance, compliance and palatability) of a high energy peptide based paediatric oral nutritional supplement for children over 12 months of age.
- Trial name
- NCT04515940
- Testing
- acceptability, tolerance and palatability study
- Where
- United Kingdom
- Volunteers
- 21 people
- Sponsor
- Société des Produits Nestlé (SPN)
Growth & Development, Formula Feeding of Healthy Full Term Infants
Evaluation of Different Protein Content of Formulas on Nutrition Status of Infants.
Human milk (HM) is the gold standard of early infant nutrition. The World Health Organization (WHO) recommend that newborns be exclusively breastfed for the first 6 months of life.
- Conditions
- Growth & Development, Formula Feeding of Healthy Full Term Infants, Breast Feeding of Healthy Full Term Infants
- Trial name
- NCT03513991
- Testing
- Infant formula
- Where
- Mexico
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Universidad Autonoma de Queretaro
Celiac Disease
A Population-based Study of Celiac Disease in South Europe in Children Between 1 to 5 Years of Age
Celiac disease (CD) was diagnosed for years almost exclusively in children. This is due to the fact that in adulthood it manifests in a much more attenuated form, while the classic form with severe diarrhea, malnutrition and…
- Trial name
- HNCEL (NCT05968404)
- Volunteers
- 3,659 people, healthy volunteers welcome
- Sponsor
- Hospital Mutua de Terrassa
Growth, Colic
Safety and Tolerance Study of Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic
The purpose of this study is to evaluate the nutritional adequacy, the digestive tolerance and the effect on colic of an alpha-lactalbumin-enriched and probiotic-supplemented infant formula.
- Trial name
- NCT00929292
- Testing
- Modilac Dahlia 1, Modilac 1
- Where
- 12 sites in France
- Volunteers
- 66 people
- Sponsor
- Sodilac
Crohn Disease
The Vitamin D in Pediatric Crohn's Disease ( ViDiPeC-2 )
The purpose of this study is to determine if vitamin D as an adjuvant therapy can improve the outcome (i.e. fewer relapses) and the quality of life, including levels of physical activity, in children diagnosed Crohn's disease…
- Trial name
- ViDiPeC-2 (NCT03999580)
- Testing
- vitamin D3
- Where
- 7 sites in Canada
- Volunteers
- 55 people
- Sponsor
- Jantchou Prevost
Necrotizing Enterocolitis, Very Low Birth Weight Infants
Splanchnic Oxygenation After the First Enteral Feed in Preterm Infants: Prediction of Feeding Tolerance.
Enteral nutrition of preterm and intrauterine growth-restricted (IUGR) infants is still a challenge for neonatologists. Due to the immaturity of the gastrointestinal tract, preterm infants are at high risk of developing feeding…
- Trial name
- NIRS-SO (NCT02383264)
- Where
- Italy
- Volunteers
- 61 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Formula Milk, Infants
Infant Formula Study With Pre- And Postbiotics
This prospective, single-arm study evaluates the gastrointestinal tolerance, safety, and growth, quality of life and gut microbiome development of healthy term infants fed a commercially available palm oil free infant formula…
- Trial name
- NCT07734532
- Testing
- Infant Formula
- Where
- Ireland
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nutricia UK Ltd
Complex Conditions, Including Impairment of the GI Tract
Neocate In Infants and Children With Complex Conditions
Infants and young children up to 10 years of age with a complex condition involving the gastrointestinal tract are at risk of poor nutritional status, including faltering growth.
- Trial name
- NICC (NCT04265729)
- Testing
- Neocate Infant and Junior marketed products
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 13 people
- Sponsor
- Nutricia Research
C.Medical Procedure; Digestive System, Disorder of Upper Gastrointestinal Tract
Lidocaine Spray on an Endoscope to Improve Tolerance to Endoscopy
The investigators tested whether a new method which additional lidocaine spray on the tip of endoscope can increase the tolerance of examinee during endoscopy than conventional pharyngeal anesthesia alone.
- Conditions
- C.Medical Procedure; Digestive System, Disorder of Upper Gastrointestinal Tract, Tolerance
- Trial name
- NCT02307773
- Testing
- Case Group
- Where
- South Korea
- Volunteers
- 497 people
- Sponsor
- Cheju Halla General Hospital
Cerebral Palsy
Acceptability and Tolerance Study of a Low Calorie Peptide Based Paediatric Tube Feed Formula.
This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of a low calorie paediatric peptide based tube feed formula for the dietary management of participants with short…
- Trial name
- NCT03718208
- Testing
- Paediatric Formula
- Where
- 3 sites in United Kingdom
- Volunteers
- 15 people
- Sponsor
- Société des Produits Nestlé (SPN)