Clinical trials: Gastro-Intestinal Tolerance
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
Neurogenic Bowel, Spinal Cord Injuries (SCI)
Transcutaneous Spinal Cord Stimulation for Bowel Management in Individuals with Motor Complete Spinal Cord Injury
The primary goals of this pilot trial are to understand the feasibility and safety of thoracolumbar transcutaneous spinal cord stimulation for neurogenic bowel management in individuals with new onset, traumatic, cervicothoracic…
- Trial name
- NCT06801431
- Testing
- Transcutaneous spinal cord stimulation
- Volunteers
- 5 people
- Sponsor
- Nova Scotia Health Authority
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)
Insulin Resistance, Glucose Tolerance
Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents
This trial is divided into different parts: Part A the EryAdo trial and Part B the EryClot trial. Part A EryAdo Trial: Childhood and adolescence are crucial periods for prevention of obesity, as obese children are five times more…
- Conditions
- Insulin Resistance, Glucose Tolerance, Body Composition, Gastrointestinal Tolerance
- Trial name
- EryAdo (NCT04966299)
- Testing
- Erythritol, Sucrose, Glucose
- Where
- Switzerland
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
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
Gastro-Intestinal Tolerance
Term Infants Fed a Partially Hydrolyzed Whey Protein-Based Formula
To assess the effects of partially hydrolyzed whey protein-based infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants.
- Trial name
- NCT04934397
- Testing
- Study Infant Formula
- Where
- 14 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Gastrointestinal, Tolerance
Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children
Purpose of this study: assess the maximum tolerated bolus dose of erythritol, delivered in a clear beverage, compared with placebo (saccharose) in 4-6 year old children.
- Trial name
- NCT02016703
- Testing
- Erythritol drink
- Where
- 3 sites in France
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- Cargill
Gastrointestinal Tolerance
Tolerance of Healthy Infants Fed Infant Formulas
The primary objective of this study is to assess the comparative gastrointestinal tolerance of normal term infants to two experimental milk-based powdered formulas compared with a standard milk-based powdered formula.
- Trial name
- NCT02401217
- Testing
- Phase 1- Arm 1 Infant Formula, Phase 2- Arm 2 Infant Formula, Phase 2- Arm 3 Infant Formula
- Where
- 6 sites in United States
- Volunteers
- 126 people
- Sponsor
- Abbott Nutrition
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
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
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
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
Gastrointestinal Tolerance
TolerUp Enteral Feeding Protocol
This prospective, observational, multi-center study will follow children with cerebral palsy who decided to switch to an enteral product that contains partially hydrolyzed protein and medium chain triglycerides as a result of…
- Trial name
- NCT03648255
- Where
- 19 sites in Turkey (Türkiye)
- Volunteers
- 133 people
- Sponsor
- Abbott Nutrition
Gastrointestinal Tolerance
The Effects of Soluble Corn Fiber on Gastrointestinal Tolerance and Fecal Microbiome in Healthy Children
The purpose of this study is to compare the effects of PROMITOR® Soluble Corn Fiber versus inulin on GI symptoms (tolerance), stool consistency (laxation) and fecal microbiome at levels that could contribute to closing the fiber…
- Trial name
- NCT05213494
- Testing
- Inulin, soluble corn fiber
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Tate & Lyle
Cerebral Palsy (CP), Oncology
Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends
This is a prospective acceptability study to evaluate the gastrointestinal tolerance and compliance of a bolus tube feed over a 28 -day period for up to 50 participants.
- Trial name
- Blends (NCT07341464)
- Testing
- Tube feed
- Where
- 2 sites in United Kingdom
- Volunteers
- 50 people
- Sponsor
- Société des Produits Nestlé (SPN)
Very Preterm Infants (<32 Weeks of Gestation)
Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants
The AdVEMPrem study is exploring whether tiny particles called extracellular vesicles (EVs), which are naturally found in human milk, can help protect very premature babies from serious gut problems such as necrotizing…
- Trial name
- AdVEMPrem (NCT07402083)
- Testing
- Donor human milk extracellular vesicles (DHM-EVs)
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Instituto de Investigacion Sanitaria La Fe