22 Clinical Trials for Various Conditions
This study is a randomized, double-blind, crossover trial aiming at evaluating the gastrointestinal tolerance of 3 sugar replacers mixes at 3 different doses. The investigators will also try to understand the factors that could explain the presence or absence of symptoms
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 gap. The dose response effects of PROMITOR® Soluble Corn Fiber in healthy children will also be compared.
Prospective, double-blind, randomized study of 2 infant formulas.
The goal of this study is to determine subjective gastrointestinal tolerance response and differences in breath hydrogen response following the consumption of two types of juice. This double-blind crossover study requires participants to arrive to the lab 12 hours fasted, consume 12 oz of juice and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen analysis at various time points over the next 3 hours. Subjects will be asked to complete additional questionnaires at 12 and 24 hours post consumption, from home. Subjects will also be asked to keep a food record for 24 hours prior to their scheduled visit times to assure compliance.
The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.
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.
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 important bacteria in the infant gut microbiome. A lack of Bifidobacterium in the infant gut may lead to disordered development of the infant microbiome and immune system, which can contribute to the development of gastrointestinal issues, pathogenic infections, and immune-related conditions including allergic disease and autoimmune disorders. The investigators hypothesize that establishing Bifidobacterium in the infant gut through delivery of a synbiotic, containing bifidobacterium and human milk oligosaccharides (HMOs; Bifidobacterium's primary nutrient source) may modulate the microbiome and correct this disruption. Research Question: Does synbiotic supplementation on infants and toddlers of various ages alter the gut microbiome as measured by GI-tolerance, fecal microbiome composition, and fecal metabolic profile? Objectives: * Demonstrate shifts in microbiome composition and metabolism * Demonstrate tolerance by observing neutral or positive shifts in GI related behaviors Study Design Overview: Participants Infants aged 2-24 months will be enrolled to evaluate the ability of a synbiotic (human milk oligosaccharide + a Bifidobacterium blend (B. infantis, B. longum, and B. breve)) to modulate the gut microbiome. Infants will be randomly split into two cohorts, one that receives synbiotic supplementation and one that receives a placebo control (lactose). Initially, only ages 12-24 months will be enrolled (first 25 participants), and a safety review will be performed prior to enrolling younger infants. Cohorts * Cohort 1 (supplementation) participants will be aged 2 months to 24 months. They will receive synbiotic supplementation for 1 month. * Cohort 2 (no supplementation) participants will be aged 2 months to 24 months. Will receive placebo (lactose) over the course of 1 month. Design Caretakers will be recruited and screened using an online questionnaire to determine eligibility and cohort assignment. They will give consent using an online one-party consent form (Appendix 1). Participants will be distributed randomly between cohorts 1 and 2. Participants will be shipped the synbiotic or placebo (lactose) and a set of stool sampling kits. Calls with the participant will take place throughout the study as necessary to explain participant responsibilities and ensure compliance. Two sample types will be collected during the study, a full fecal sample and a DNA/RNA tube only. The full fecal sample will be collected at the beginning and end of supplementation and the DNA/RNA tube only will be collected at all other time points. Samples will be collected at supplementation start, one week after supplementation, four weeks after supplementation start (coinciding with the end of supplementation) and 6 weeks after supplementation start (coinciding with a 2 week washout period). Journals and questionnaires will be used for the duration of supplementation as well as 2 weeks before and after to assess the impact of supplementation. Laboratory Assessments: Stool samples will be obtained for each subject. The first sample will be taken before supplementation start. Additional samples will be collected: after 1 week of supplementation, after 1 month of supplementation, and after a 2 week period of no supplementation (a washout period). All samples will be collected at home and shipped back to Persephone Biosciences for processing. The initial sample and the sample after 4 weeks of supplementation will be full samples for metagenomic, metabolomic, and proteomic analysis. The 1 week after supplementation and 2 week post supplementation samples will be DNA/RNA tube samples for metagenomics only. Microbial whole genome sequencing, metabolite analysis, and immune profiling will be performed on stool from complete stool kits. Microbial whole genome sequencing alone will be performed on the DNA/RNA tube kits. Data Collection: Demographic data, general health information, diet and lifestyle information will be collected from the subjects (all self-reported). Journals and questionnaires will be used to evaluate the impact of the synbiotic.
The purpose of this non-randomized, multi-center study is to evaluate the growth, tolerance and compliance of an extensively hydrolyzed infant formula in an intended use population of infants.
This is a prospective, randomized, multicenter study to assess the tolerance of infant formulas.
To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on symptoms of formula intolerance in healthy term infants.
This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.
This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term infants with reported intolerance to a milk-based formula.
This study assessed tolerance improvement of a formula change in healthy term infants with perceived intolerance to their current milk-based formula feeding.
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.
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.
The intake of inulin products has been linked to multiple health benefits which has lead to inulin fortification in food products. The investigators hypothesis that doses of up to 10 grams of inulin products should be well tolerated and not result in a significant increase in gastrointestinal symptoms.
To assess the effects of partially hydrolyzed whey protein-based infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants.
To assess the effects of infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants
The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.
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.
The objective of this study is to evaluate gastrointestinal tolerance of an oral nutritional supplement containing a new protein blend in healthy elderly subjects.
The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula.