The purpose of this study is to evaluate the effect of the probiotic product on the GI tract flora composition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
133
Biostime probiotics sachet children's formula,1.5g Oral Single dose
Biostime probiotics sachet children's formula(placebo),1.5g Oral Single dose
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, China
Proportion of Participants Achieving the modulatory effect on the GI tract flora composition after the intervention.
GI tract flora include Bifidobacterium, Lactobacillus, Clostridium perfringens, Enterococcus, Enterobacter, Bacteroides. Modulatory effect of GI tract flora composition was defined as two definitions. The first definition is that Lactobacillus and/or Bifidobacterium increases significantly, Clostridium perfringens decreases or has no change and Enterococcus, Enterobacter, Bacteroides has no obvious change. The other is that Lactobacillus and/or Bifidobacterium increases significantly, Clostridium perfringens decreases or has no change, Enterobacter and/or Enterococcus, Bacteroides increases significantly, but the amplification less than Lactobacillus/Bifidobacterium.
Time frame: From Baseline to week 4
Change of Lactobacillus helveticuspopulations in stool
Time frame: From Baseline to week 4
average daily number of stools
Time frame: From Baseline to week 4
Aaverage daily Infant Stool Form scores consistency
Time frame: From Baseline to week 4
Average weekly Infant Stool Form scores amount
Time frame: From Baseline to week 4
Average weekly Infant Stool Form scores color
Time frame: From Baseline to week 4
Average daily number of crying episodes
Time frame: From Baseline to week 4
Average daily duration of crying episodes
Time frame: From Baseline to week 4
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sIgA antibody levels in stool
Time frame: From Baseline to week 4
sIgA antibody levels in saliva
Time frame: From Baseline to week 4
change in infant weight
Time frame: From Baseline to week 4
change in infant length
Time frame: From Baseline to week 4
change in infant head circumference
Time frame: From Baseline to week 4
The number of AE and SAE
Time frame: From Baseline to week 4