Comparison of two probiotics in follow-on formula: Bifidobacterium animalis subsp. lactis HN019 reduced upper respiratory tract infections in Chinese infants.

2022-10-04
Beneficial microbes 13(4)
- J Dekker
- M Quilter
- H Qian

PubMed: 36004715
DOI: 10.3920/bm2022.0041

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 192
Population: 192 healthy infants aged six to 12 months in Fuyang (Anhui Province, China)
Methods: randomised, double-blind, placebo-controlled trial; infants received one of three follow-on formulae daily for 12 weeks: supplemented with 10^6 cfu/g Bifidobacterium animalis subsp. lactis HN019 (n=64); 10^6 cfu/g Lacticaseibacillus rhamnosus HN001 (n=64); or without added probiotics (n=64)
Blinding: Double-blind
Duration: 12 weeks
Funding: Unclear

Large Human Trial
Rigorous Journal

A randomised, double-blind, placebo-controlled trial was performed to investigate the health benefits of probiotic bacteria in infants when delivered in a follow-on infant formula. The study was conducted in Fuyang (Anhui Province, China) during winter and enrolled 192 healthy infants aged six to 12 months. Infants received one of three follow-on formulae daily for 12 weeks: supplemented with 10⁶ cfu/g Bifidobacterium animalis subsp. lactis HN019 (n=64); 10⁶ cfu/g Lacticaseibacillus rhamnosus HN001 (n=64); or without added probiotics (n=64). The primary endpoint was physician-confirmed bacterial or viral infections during the treatment period. Secondary endpoints included parentally reported (confirmed and unconfirmed) infections; antiviral or antibiotic treatments, and hospitalisation; stool frequency and consistency; infant growth; infant temperament; and adverse events. There were 8 cases of confirmed infection, all upper respiratory tract infections (URTIs). Confirmed URTIs were observed in 9.4% of the control group, compared to 3.1% in the HN001 group (P=0.273), and 0.0% in the HN019 group (P=0.028). A similar trend was observed for parentally reported URTIs, with 25.0% in the control group, compared with 14.1% in the HN001 group (P=0.119) and 9.4% in the HN019 group (P=0.019). No infants in the HN019 group were prescribed antibiotics or antivirals, compared with 3 (4.7%) in the HN001 group and 7 (10.9%) in the control group. No infants required hospitalisation. The probiotic-containing formulae were well-tolerated: there were no cases of diarrhoea or differences in stool frequency or characteristics, no differences in infant growth or temperament, and no treatment-related adverse events. This study directly compared the benefits of two different probiotics when added to follow-on infant formula at 10⁶ cfu/g and consumed over a 12-week period. While HN001 showed trends toward reduced infections, HN019 showed better performance in terms of significantly reduced incidence of both physician-confirmed and parentally reported URTIs, and antibiotic/antiviral use compared to a control in Chinese infants. The trial is registered at ClinicalTrials.gov (NCT01724203).

Research Insights

Bifidobacterium animalis subsp. lactis HN019→Improved Growth in Infants
no differences in infant growth or temperament
Effect
Neutral
Effect size
Small
Dose
10^6 cfu/g in follow-on formula (daily for 12 weeks)
Bifidobacterium animalis subsp. lactis HN019→Improved Stool Consistency
no differences in stool frequency or characteristics
Effect
Neutral
Effect size
Small
Dose
10^6 cfu/g in follow-on formula (daily for 12 weeks)
Bifidobacterium animalis subsp. lactis HN019→Improved Stool Frequency
no differences in stool frequency or characteristics
Effect
Neutral
Effect size
Small
Dose
10^6 cfu/g in follow-on formula (daily for 12 weeks)
Bifidobacterium animalis subsp. lactis HN019→Improved Temperament
no differences in infant growth or temperament
Effect
Neutral
Effect size
Small
Dose
10^6 cfu/g in follow-on formula (daily for 12 weeks)
Bifidobacterium animalis subsp. lactis HN019→Reduced Antibiotic or Antiviral Prescription
No infants in the HN019 group were prescribed antibiotics or antivirals, compared with 3 (4.7%) in the HN001 group and 7 (10.9%) in the control group.
Effect
Beneficial
Effect size
Moderate
Dose
10^6 cfu/g in follow-on formula
Bifidobacterium animalis subsp. lactis HN019→Reduced Hospitalization Rate
No infants required hospitalisation.
Effect
Neutral
Effect size
Small
Dose
10^6 cfu/g in follow-on formula (daily for 12 weeks)
Bifidobacterium animalis subsp. lactis HN019→Reduced Upper Respiratory Infections
Confirmed URTIs were observed in 9.4% of the control group, compared to 3.1% in the HN001 group (P=0.273), and 0.0% in the HN019 group (P=0.028).
Effect
Beneficial
Effect size
Large
Dose
10^6 cfu/g in follow-on formula
Bifidobacterium animalis subsp. lactis HN019→Reduced Upper Respiratory Tract Infection Episode
A similar trend was observed for parentally reported URTIs, with 25.0% in the control group, compared with 14.1% in the HN001 group (P=0.119) and 9.4% in the HN019 group (P=0.019).
Effect
Beneficial
Effect size
Moderate
Dose
10^6 cfu/g in follow-on formula

Adverse Events Reported

Bifidobacterium animalis subsp. lactis HN019→Overall tolerability
The probiotic-containing formulae were well-tolerated: there were no cases of diarrhoea or differences in stool frequency or characteristics, no differences in infant growth or temperament, and no treatment-related adverse events.
Finding
Reported
Bifidobacterium animalis subsp. lactis HN019→diarrhoea
there were no cases of diarrhoea
Finding
Reported
Bifidobacterium animalis subsp. lactis HN019→hospitalisation
No infants required hospitalisation.
Finding
Reported
Severity
Serious adverse event