Clinical trials: Gastro-Intestinal Tolerance
Conditions Influencing Health Status
Effects of Probiotics in Immune System of Healthy Adults
The present report describes the design of a clinical trial performed on healthy adult individuals to check whether the daily intake of the new Hero strains contribute to intestinal colonization, under safe and tolerable…
- Trial name
- SETOPROB (NCT01479543)
- Testing
- Probiotic CNCM I-4034, Probiotic CNCM I-4035, Probiotic CNCM I-4036
- Where
- 4 sites in Spain
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Hero Institute for Infant Nutrition
Food Allergy, Eosinophilic Esophagitis
Molecular Basis of Food Allergy
The Study examines the molecular basis of food allergy. It explores the interaction between T cells, InKT cells, basophils and cytokines in the development of food allergy.
- Trial name
- NCT01832324
- Where
- United States
- Volunteers
- 5,300 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Satiation, Gastrointestinal Tolerance
Gastrointestinal Tolerance, Satiation and Sensory Acceptance of Yogurts Containing Dietary Fiber and Coffee Cascara Extract
Coffee processing byproducts, such as coffee cascara (outer skin and pulp of the coffee berry), have potential health promoting properties due to the presence of bioactive compounds.
- Conditions
- Satiation, Gastrointestinal Tolerance, Organoleptic Appreciation
- Trial name
- NCT03539146
- Testing
- Dietary fiber, Control yogurt
- Where
- Spain
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- National Research Council, Spain
Bacterium; Agent
Colonization and Persistence of Bifidobacterium Longum
Healthy adults referred to as the absence of intestinal disorders, liver and kidney problems, lactose intolerance, and no use of ongoing medication for chronic diseases will be recruited.
- Trial name
- NCT01650753
- Testing
- Probiotic Powder
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Nebraska Lincoln
Energy Intake, Gastrointestinal Hormones
Effects of Oral Pre-loads on Subsequent Energy Intake
The aim of this project is to investigate the effect of erythritol (given as pre-load), compared to sucrose, sucralose, and water on energy intake during a subsequent ad libitum test meal in healthy participants.
- Conditions
- Energy Intake, Gastrointestinal Hormones, Glycemic Control, Appetite
- Trial name
- NCT04713137
- Testing
- Erythritol, Sucrose, Sucralose
- Where
- Switzerland
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
Blood Glucose, High
A Personal Microbiome-dependent Glucose Response in Healthy Young Volunteers
Individuals eating identical meals present high variability in post-meal blood glucose response making comparisons challenging. This study evaluates in 40 healthy and fasted participants whether the postprandial glucose response…
- Trial name
- MIGLUCOSE (NCT03686293)
- Testing
- Standardized breakfast
- Where
- Denmark
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of Copenhagen
Gastrointestinal Discomfort, Performance Status
A Safety/Tolerance Phase, Ascending Single Dose Study to Evaluate the Safety and Tolerability of G3P-01, a Food-Grade Pectic Product, in Healthy Volunteers
This is an interventional, open-label study to evaluate the safety, tolerability and PK of escalating single doses of G3P-01 in 10 healthy adult subjects.
- Trial name
- G3P-01-01 (NCT05296083)
- Testing
- G3P-01
- Where
- Netherlands
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- SQ Innovation, Inc.
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
Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)
TOLerogenic Potential of Hematopoietic Stem and Progenitor Cells and Inflammatory Bowel Disease
Pediatric refractory Inflammatory Bowel Disease (IBD) is a chronic inflammatory condition of the gastrointestinal tract, not responsive to current treatments.
- Trial name
- TOL-IBD (NCT07740499)
- Testing
- biological sample collection: an additional volume of peripheral blood (3-10 ml), biological sample collection: small fragment (1-5 mm) of intestinal tissue - residual or leftover material, biological sample collection: leftover peripheral blood samples from healthy subjects
- Where
- 2 sites in Italy
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- IRCCS San Raffaele
Lower Gastrointestinal Disorder, Tolerance
A Pilot Study of Commercially Available Bowel Preparation Regimens Packaged and Ingested Via Vegan Capsules
The goal of this clinical trial is to learn whether bowel preparation powders used before colonoscopy can be taken as capsules instead of being mixed and drunk as a liquid.
- Trial name
- CLEAR-CAP (NCT07700277)
- Testing
- Sodium picosulfate, magnesium oxide, and citric acid capsules, Polyethylene glycol 3350 with electrolytes capsules
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Ottawa Hospital Research Institute
Gastrointestinal Motility Disorder, Dyspepsia
The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity
Functional Dyspepsia-Postprandial Distress Syndrome (FD-PDS), is characterized by meal-related symptoms such as early satiation and postprandial fullness.
- Trial name
- NCT04429802
- Testing
- Prucalopride
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Steatorrhea, Growth
Tolerance and Digestibility of a New Formula in Healthy Infants
The great majority of infants formula contain fats exclusively from vegetable oil. Nevertheless, the use of both vegetable and dairy lipids is on a real interest to obtain an infant formula closer to the nutritional composition…
- Trial name
- NCT01184378
- Testing
- dairy lipids and soluble milk proteins
- Where
- 2 sites in France
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Lactalis
Feeding; Disorder, Nonorganic Origin, Calcium Disorder
Evaluation of the Effect of Palm Olein Free Formula on Intestinal Flora and Gastrointestinal Tolerance
Depending on recent studies in literature the investigators aimed to compare whether gastrointestinal tolerance differs between infants fed with palm olein containing or palm olein free formulas.
- Conditions
- Feeding; Disorder, Nonorganic Origin, Calcium Disorder, Intestinal Bacteria Flora Disturbance
- Trial name
- NCT03770143
- Testing
- Feeding with palm olein formula
- Where
- Turkey (Türkiye)
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
Gastroesophageal Reflux, Esophageal Varices
A Study of Disposable Transnasal Esophagoscope
This is a pilot study of a novel disposable transnasal esophagoscope for feasibility, safety and tolerance.
- Conditions
- Gastroesophageal Reflux, Esophageal Varices, Esophageal Disease
- Trial name
- NCT01360515
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Yonsei University
Inflammatory Bowel Diseases
Multiple-dose Escalation Clinical Study of VC005 Tablets in Healthy Subjects
This clinical trial is a randomized, double-blind, single-center, placebo-controlled and multiple-dose escalation Pharmacokinetics study
- Trial name
- NCT05354752
- Testing
- VC005 tablets
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
Growth, Tolerance
Human Milk Oligosaccharides (HMOs) Post-market Study on Infants
Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT).
- Conditions
- Growth, Tolerance, Adverse Event, Disorder of Intestine
- Trial name
- NEHMO (NCT04055363)
- Testing
- HMO-supplemented infant formula
- Where
- 6 sites in Spain
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Shigella
Safety and Efficacy Study of CVD 1208S, a Live, Attenuated Oral Vaccine to Prevent Shigella Infection Using cGMP
The purpose of this study is to determine whether CVD 1208S (a live, attenuated, oral vaccine) is safe and effective in the prevention of Shigella infection.
- Trial name
- NCT01531530
- Testing
- CVD 1208S, a Shigella flexneri 2a live, oral vaccine
- Where
- 2 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Tolerance, Healthy Population
Evaluating the Impact of Different Sugar Replacer Combinations on Gastrointestinal Tolerance
This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of 3 sugar replacers mixes at 3 different doses.
- Trial name
- NCT05794100
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Mondelēz International, Inc.
Gastrointestinal Tolerance, Healthy Population
Evaluating the Impact of Incremental Doses of a Sugar Replacer Blend on Gastrointestinal Tolerance in Chocolate
This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of sugar replacer ingredients and blends (maltitol, kestose (Oligofructose), kestose + cocoa and polydextrose premix at…
- Trial name
- NCT06479330
- Testing
- Milk Chocolate
- Where
- Canada
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Mondelēz International, 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