6 výsledky
Objectives:
The main objective of this study is to document the growth and feeding tolerance of healthy term infants consuming an infant formula supplemented with HMOs for 8 weeks (56 days), in a real-world setting.
Main endpoints:
1. Growth documented via monitoring the anthropometric parameters
Aim 1/Objective 1. Establish the feasibility of oligosaccharide supplementation and twice a week stool collections among 12 C. difficile colonized hematology-oncology inpatients. It will be determined if at least 70% of the oligosaccharide dosages are taken by at least 8 (>=66%) of the 12 enrolled
Only adults>18YO will be included, Two cohorts will be included: A cohort of CD patients (including specific sub-cohorts of recruited known & new-onset CD and travelling CD patients and archived pathological specimens of post-operative CD, total n=300) and a cohort of controls (healthy individuals
Specific Objectives:
To evaluate the microbiome response to probiotic supplementation (with and without prebiotics) in under 6 months infants with severe acute malnutrition and to compare the microbiome response with healthy infants supplemented with probiotic.
Research Design and Methods:
Study
The proposed phase I clinical trial is a parallel-group, placebo-controlled, randomized, double-blind ascending dose study of dietary supplementation with Bifidobacterium longum subsp. infantis (B. infantis) in healthy breastfed infants to evaluate its safety as well as determine the
Fifty infants per group will be enrolled (n=150) and randomly divided in three groups, from those identified in selected villages in the catchment area of the Kikoneni Health Clinic in southern coastal Kenya, about 2 hours south of Mombasa. All children whose caregivers agree to participate in the