Here the investigators propose to preliminarily investigate the safety and effects of probiotics in infants in Bangladesh through a pilot randomized clinical trial. The investigators hypothesize that two probiotics are safe for infants in Bangladesh and may have an effect on biomarkers of gut health and immunity. The specific aims of this pilot are: i) to confirm the safety of administering probiotic strains to infants in low-income countries, ii) to determine the effects of dosing frequency on colonization and persistence of probiotics in the GI tract, iii) to measure markers of intestinal and immune function and microbiota structure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
160
10\^8 CFU
10\^9 CFU
International Center for Diarrheal Disease Research, Bangladesh
Dhaka, Bangladesh
Presence of probiotic in the stool
presence of absence of each probiotic in the stool
Time frame: weeks 0-12
Adverse events
Any adverse or allergic reactions after probiotic administration, hospitalizations, GI and respiratory symptoms
Time frame: duration of study - through study completion
quantity of probiotic in the stool
amount of each probiotic present in the stool
Time frame: weeks 0-12
composition of microbiota
microbial community composition
Time frame: weeks 0-12
clinical effects
fever, diarrhea, wheezing, rash, stool frequency, feeding frequency
Time frame: daily for 7 days after first probiotic administration, then weeks 2-12
gut function
lactulose/mannitol ratio
Time frame: months 0, 1, 2, 3
gut inflammation
fecal neopterin, alpha-1 antitrypsin, and myeloperoxidase - correlated with future growth
Time frame: months 0,1,2,3
gut inflammation/translocation
IL22, CD-14, total IgG and c-reactive protein
Time frame: months 0, 1, 2, 3
growth
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weight, length, head circumference
Time frame: month 0, 1, 2, 3
breastfeeding rates
Time frame: month 0, 1, 2, 3