|n/a||France||66 infants||1 month||Term infants identified with colic a at enrollment (3 w to 3 months) multicenter double-blind randomized controlled trial (DBRCT)
Standard infant formula (IF) (Control) and,
IF + B. infantis M63.
Feeding-related GI adverse events (e.g., vomiting, constipation, regurgitation, and flatulence) were significantly lower in infant receiving M63.
|France||97 infants||6 months||Term infants (<postnatal day [PND] 3 at enrollment.|
standard IF (Control), and
IF + M63.
Stool samples collected at 1 and 6 months.
manifestation of atopic dermatitis,
fecal secretory IgA (SIgA),
fecal microbiota composition.
Probiotic diet was safe, well-tolerated and protective against the development of atopic dermatitis. M63 group exhibited less crying or agitation, and more quiet behavior after 1 month of feeding (p < 0.02).
| ||n/a||Italy||55 children (4–12 years old [yo]) with functional constipation.||8 weeks||Prospective, placebo-controlled, randomized trial|
polyethylene glycol (PEG; laxative), and
PEG + Probiotics: M63 + B. breve M16 + B. longum BB536.
Frequency of bowel movements,
Stool consistency according to the Bristol stool form scale,
presence of fecal incontinence,
painful defecation, and
|Italy||40 children (9 yo) with allergic rhinitis and asthma.||4 weeks||Prospective, placebo-controlled, randomized trial|
probiotics: M63 + M16 + BB536, and
Quality of life (QoL), frequency and school performance,
evaluation of asthma exacerbations
|Italy||73 children (8–16 yo) with abdominal pain (AP)-associated functional GI disorders (FGID).||6 weeks||Prospective, placebo-controlled, randomized trial|
probiotics: M63 + M16 + BB536, and
| ||not known||Japan||44 infants (low-birthweight).||6 weeks|
probiotic mixture: M63 + M16 + BB536
|US||12 premature infants.||5 weeks||2013 |
|US||24 infants with gastroschisis.||6 weeks|
(or hospital discharge)
ATCC 15697 (1 billion CFU twice daily) and
Control (powdered elemental formula).
|UCD272 (Culture Systems Inc)||ClinicalTrials.gov|
(listed as SC268)
|US||11 children (2–11 yo) with ASD||12 weeks||DBRC|
bovine colostrum (prebiotic) + UCD272 20 billion CFU/day, and
|21 days||Randomized, parallel assignment|
lactation support (LS), and
LS + EVC001 b
stool samples collected through PND 60.
Significantly higher stool Bifidobacterium spp. in infants receiving EV0001,
no differences in health and safety outcomes, and
significantly lower daily stool frequency in EVC001 infants.
| || || || || || |
16S rRNA sequencing and
|In infants who received EVC001:|
significantly higher Bifidobacteriaceae and B. infantis,
lower stool HMO (suggesting increased metabolism by bifidobacteria),
lower stool pH and higher acetate and lactate, and
significantly higher stool B. infantis for 30 days following end of feeding period.
| || || || || || |
87.5% fewer antibiotics resistant genes (ARG) detected in the microbiome, and
significant reduction in abundance of Escherichia.
| || || || || || ||2018|
| || || || || || ||2019 |
|Spain||151 term infants||12 weeks ||Multicenter DBRCT|
Standard IF (Control), and
IF + CECT 7210
|In CECT 7210 group:|
No differences were found in other digestive symptoms, growth, or formula intake.
|2018  |
|BB-02 (Chr. Hansen)||Australia|
and New Zealand Clinical Trials Register,
|Australia/New Zealand||1099 preterm infants||Through hospital discharge|
or term corrected age
Maltodextrin (placebo), and
probiotic combination: BB02, Streptococcus thermophilus Th4, and Bifidobacterium lactis BB12.
NEC (Bell stage 2 or more), mortality, length of hospital
stay, and weight at discharge.
|Incidence of NEC was significantly reduced in infants receiving the probiotic combination but not definite late-onset sepsis or mortality.||2013 |
| || || || || || ||Higher levels of Bifidobacterium spp. found in infants who received the probiotics; Enterococcus reduced in infants receiving the probiotic mix during the supplementation period||2018 |
|R0033 (Lallemand)||Clinicaltrials.gov NCT02215304||Spain||221 infants ||8 weeks||Multicenter DBRCT|
Potato starch (placebo), R0033 (3 billion CFU/d), Bifidobacterium bifidum R0071, and
Lactobacillus helveticus R0052.
Urine concentration of D-lactic acid,
changes in sleep and crying patterns, and
immune compounds in fecal samples.
|Use of R0033 was safe and well tolerated. No impact on growth (weight, height, and head circumference), adverse events, or serious adverse events.|
Increased ratio of IL-10/IL-12 and significant reduction in Collinsella, Enterococcus, and Klebsiella genera in infants receiving R0033.
| || || ||135 children|
|3 months||Multicenter DBRCT|
Synbiotic preparation (R0033, L. helveticus R0052, B. bifidum R0071, and FOS), and
|Percentage of children free of any episodes of ear, nose and throat,|
respiratory tract, or gastrointestinal illness
|Synbiotic preparation decreased the risk of occurrence of common infectious diseases. No side effects were detected in either group.||2010 |
|Germany||106 infants||12 months||Double-blind, randomized, placebo-controlled study|
BT1, B. bifidum BF3, B. breve BR3, B. longum BG7 (total 10 million CFU/g), and
Composition of the fecal microbiota (16s rRNA sequencing) and fecal metabolome (HPLC).
||Probiotic formula modulated the infant stool microbiome (e.g., Bacteroides) and metabolome (e.g., lipids) at very early stages of life, with no detectable long-term consequences.||2017 |