Byte Sized Summary: A “microbial preparation”. Read more for context.
If there were an abstract for a clinical study that read like a movie teaser, it might read like the following:
The gastrointestinal (GI) tract of a fetus in utero is sterile but it becomes colonized with environmental microorganisms shortly after birth. Since the gut microbiota undergoes substantial changes in early life, healthy gut microflora is essential to an infant’s gut health and immune system and probably also has an effect on overall health status in later life.
Byte sized translation: Biota and Flora refer to the organisms (little “bugs”) that live inside your intestines. Often, these are good guys and the subject of much research.
The following portion of the abstract has one reasonable definition of probiotics and their effects on infants.
For new readers, probiotics are live organisms (sometimes spores), and this concept understandably makes some consumers uneasy.
Probiotics, defined as viable microbial preparations that have a beneficial effect on the health of the host, represent a rapidly expanding field. Although randomized controlled trials using probiotics in infants have shown promising results in the prevention and treatment of common diseases such as diarrhea and allergy, little is known about whether probiotics could offer benefits to healthy infants.
The title of the upcoming study is Effect of probiotics on digestibility and immunity in infants: A study protocol for a randomized controlled trial, link to the PubMed Abstract here. You can also access the study design images.
If you would like to learn more about probiotics, please let us know by posting a comment on the bottom of this page. As always, thanks for reading.
For those super-nerds out there (us included), here is the rest of the abstract:
The trial will be a randomized, double-blind, placebo-controlled, 2-parallel-group study in Shanghai, China. After a 2-week run-in period, 200 exclusively formula-fed healthy infants aged 4 to 6 months will be randomly allocated to receive either a probiotic product containing Bifidobacterium infantis R0033, Bifidobacterium bifidum R0071, and Lactobacillus helveticus R0052 or an identical placebo once daily for 4 weeks and will be followed up for 8 weeks. The duration of the subject’s participation will be 14 weeks, with a total of 5 visits: inclusion (Visit 1, Day 1), start of intervention (V2, D15), end of intervention (V3, D44), and follow-up (V4 and V5, D72 and D100). Stool and saliva samples will be collected at the first 3 visits to measure microbial populations and secretory immunoglobulin A (SIgA), respectively. Physical examination will be performed at each visit, and tolerance records will be completed 1 day prior to each visit. The primary endpoints will be the changes in the composition of fecal microbiota, particularly the Bifidobacterium bifidum population. The secondary endpoints will include the change in salivary SIgA level, growth parameters, digestive tolerance, and adverse events.An effective, practical, and acceptable probiotic intervention in manipulating the gut microbiota and boosting the immune system in formula-fed infants would represent a major clinical advance. The administration of probiotic supplementation or follow-on formula to infant may be associated with some clinic benefits.
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