Clinical trials: Gastro-Intestinal Tolerance
- Condition Gastro-Intestinal Tolerance
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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
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)
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)
Gastrointestinal Tolerance of Probiotics in Infants
Evaluating the Impact of Synbiotic Supplementation on Infants and Toddlers
Background and Significance: Bifidobacterium longum subspecies infantis (B. infantis) and other infant associated Bifidobacterium (such as Bifidobacterium longum subspecies longum and Bifidobacterium breve) are known to be…
- Trial name
- NCT06746285
- Testing
- Synbiotic Supplement
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Persephone Biosciences
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
Gastrointestinal Tolerance
Behavior of Infants Fed Formula Supplemented With Prebiotics
To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on symptoms of formula intolerance in healthy term infants.
- Trial name
- NCT02757924
- Testing
- Infant formula supplemented with prebiotics
- Where
- 11 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Gastrointestinal Tolerance
Gastrointestinal Tolerance of Infant Formula
The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.
- Trial name
- NCT02322138
- Testing
- Experimental 1 Infant Formula, Experimental 2 Infant Formula, Reference Group
- Where
- 10 sites in United States
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Gastrointestinal Tolerance, Gastrointestinal Symptoms
Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula
This randomized controlled double-blind study will compare the effect of a commercially available goat milk formula to a cow's milk formula on gastrointestinal symptoms and tolerance, and infections in infants.
- Conditions
- Gastrointestinal Tolerance, Gastrointestinal Symptoms, Infections, Quality of Life
- Trial name
- MESK-2 (NCT07342972)
- Testing
- Goat milk-based infant formula, Cow's milk-based infant formula
- Where
- Saudi Arabia
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Ausnutria Hyproca B.V.
Infant, Gastrointestinal Intolerance
Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula
The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula.
- Trial name
- NCT01573871
- Testing
- Experimental Hydrolyzed infant formula
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Abbott Nutrition
Gastrointestinal Diseases, Feeding Intolerance
Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population
The objective of this study is to determine the safe use and tolerance of a peptide-based formula in children with gastrointestinal dysfunction and/or feeding intolerance.
- Trial name
- NCT01191112
- Testing
- Peptide based enteral formula
- Where
- Canada
- Volunteers
- 27 people
- Sponsor
- Abbott Nutrition
Gastrointestinal Problems
Assessment of Efficacy and Tolerance of a Follow-On Milk Containing a Mixture of Prebiotics Fed to Young Children in Salvador, Bahia, Brazil
This clinical study will evaluate the effect on incidence of diarrhea, respiratory illness, stool patterns and growth of two cow's milk-based beverages for children.
- Trial name
- NCT01177605
- Testing
- Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics
- Where
- Brazil
- Volunteers
- healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Infantile Colic
Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic
The study is conducted to examine the safety and efficacy of a new infant formula and its effects on the gastrointestinal tolerance in infants suffering from colic.
- Trial name
- Coco (NCT01721850)
- Testing
- control formula, intervention formula 1, intervention formula 2
- Where
- 18 sites in Germany, Italy
- Volunteers
- 169 people, healthy volunteers welcome
- Sponsor
- HiPP GmbH & Co. Vertrieb KG
Gastro-Intestinal Tolerance
Tolerance of an Oral Nutritional Supplement(ONS)
The objective of this study is to capture information on gastrointestinal tolerance (GI) of an oral nutritional supplement containing a new protein blend in healthy children aged ≥ 3 to ≤ 10 years.
- Trial name
- NCT01782456
- Testing
- Study Oral Nutritional Supplement
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Regurgitation, Gastric
Evaluation of the Tolerance and Safety of a New Partly Fermented Anti-regurgitation Infant Formula
A randomised, controlled, double-blind trial to evaluate the tolerance and safety of a new partly fermented anti-regurgitation infant formula containing prebiotics and locust bean gum in infants with regurgitation.
- Trial name
- Leopard (NCT03371615)
- Testing
- Anti-regurgitation infant formula
- Where
- 2 sites in Poland
- Volunteers
- 182 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
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)
Infant, Newborn
Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants
The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental soy-based formulas, relative to a commercially available soy-based formula.
- Trial name
- NCT00798382
- Testing
- soy protein formula, Commercially available soy formula, Soy formula experimental #2
- Where
- 17 sites in United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Dysphagia
Acceptability and Tolerance Study of a Thickener
This is a prospective, acceptability study to evaluate the gastrointestinal tolerance and compliance of a thickener for the management of reflux, GORD and dysphagia
- Trial name
- NCT05026476
- Testing
- Resource Thicken up Junior
- Where
- United Kingdom
- Volunteers
- 21 people
- Sponsor
- Société des Produits Nestlé (SPN)
Gastrointestinal Tolerance
Tolerance of Infants Fed a Hydrolysate Formula
This is a prospective, randomized, multicenter study to assess the tolerance of infant formulas.
- Trial name
- NCT03628183
- Testing
- Hydrolysate Infant Formula 1, Hydrolysate Infant Formula 2
- Where
- 5 sites in United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
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)
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