Clinical trials: Gastrointestinal Tolerance
- Condition Gastrointestinal Tolerance
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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
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 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
Nutrition Disorders
Acceptability and Tolerance Study of a Plant-based Tube Feed
This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 7-day period with a plant based tube feed.
- Trial name
- NCT06209593
- Testing
- Compleat plant protein tube feed
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Société des Produits Nestlé (SPN)
Growth, Allergy
Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein
The purpose of this study is to assess growth and global tolerance in healthy new born infants with minor gastrointestinal troubles and/or allergic risk, fed an experimental partially hydrolyzed rice protein infant formula.
- Trial name
- Rose (NCT00997971)
- Testing
- Modilac Rose 1
- Where
- 9 sites in France
- Volunteers
- 86 people
- Sponsor
- Sodilac
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
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)
Gastrointestinal Tolerance
Effect of Formula on Infant Behavior
This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.
- Trial name
- NCT02746016
- Testing
- Infant Formula supplemented with Oligosaccharides
- Where
- 13 sites in United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Candidiasis, Esophageal, HIV Infections
A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.
- Trial name
- NCT00002304
- Testing
- Ketoconazole, Fluconazole
- Where
- 42 sites in United States, Canada
- Sponsor
- Pfizer
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
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
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, Full-term Infants Who Are Formula-fed
Gastrointestinal Tolerance Evaluation of an Infant Formula
Prospective, double-blind, randomized study of 2 infant formulas.
- Trial name
- NCT03307122
- Testing
- Routine Infant Formula 1, Routine Infant Formula 2
- Where
- 8 sites in United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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
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)
Paediatric
Vegetarian Tube Feed Study
This is a single arm, prospective, single-centre study to evaluate the gastrointestinal tolerance and compliance over a 28-day period using a tube feed with food derived ingredients.
- Trial name
- Tube feed (NCT07378111)
- Testing
- paediatric tube feed
- Volunteers
- 25 people
- Sponsor
- Société des Produits Nestlé (SPN)
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
Cystic Fibrosis
A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)
This was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme.
- Trial name
- NCT00434278
- Testing
- Dornase alfa
- Where
- 40 sites in United States
- Volunteers
- 27 people
- Sponsor
- Genentech, Inc.
Regurgitation, Gastric, Diarrhea
To Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation
A randomized, controlled study to evaluate the safety and tolerance of an infant formula with locust bean gum in infants with regurgitation. (Solar)
- Trial name
- Solar (NCT04042454)
- Testing
- milk based anti-regurgitation infant formula, Milk based infant formula
- Where
- 16 sites in Italy, Poland and 1 more
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Nutricia Research