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Updated: Dec 8, 2025
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Published on: January 27, 2019
Bifidobacterium breve BBG-001 and intestinal barrier function in preterm babies: Exploratory Studies from the PiPS
Paul Fleming1,2, Mark Wilks3,4, Simon Eaton5
1Homerton University Hospital, NHS Foundation Trust, London, UK. Paul.fleming@qmul.ac.uk.
Insights
Probiotics like Bifidobacterium breve BBG-001 did not prevent necrotising enterocolitis (NEC) in preterm infants. Mechanistic studies suggest this probiotic did not improve intestinal barrier function, highlighting the need for efficacy-tested strains in future trials.
Area of Science:
- Neonatal Medicine
- Microbiology
- Gastroenterology
Background:
- Necrotising enterocolitis (NEC) prevention by probiotics remains uncertain due to varied strains lacking efficacy evidence.
- Mechanistic studies assessing probiotic properties could guide the selection of effective strains for NEC prevention.
Purpose of the Study:
- To investigate the effects of Bifidobacterium breve BBG-001 on intestinal barrier function in preterm infants.
- To determine if mechanistic data can identify probiotic strains with therapeutic potential for NEC prevention.
Main Methods:
- Assessed intestinal permeability, stool microbiota, short-chain fatty acids (SCFAs), and mucosal inflammation in preterm infants during a randomized controlled trial of B. breve BBG-001.
- Compared results based on probiotic allocation and stool colonization.
Main Results:
- B. breve BBG-001 colonization was confirmed, with increased Enterobacteriaceae and acetic acid levels.
- No significant differences were observed in intestinal barrier function measures.
- The trial found no evidence that B. breve BBG-001 reduced NEC incidence.
Conclusions:
- The failure of B. breve BBG-001 to improve intestinal barrier function or prevent NEC suggests it lacks therapeutic potential.
- Embedded mechanistic tests show promise for identifying probiotic strains suitable for large-scale NEC prevention trials.
Background:
Uncertainty remains about the role of probiotics to prevent necrotising enterocolitis (NEC) some of which arises from the variety of probiotic interventions used in different trials, many with no prior evidence of potential efficacy. Mechanistic studies of intestinal barrier function embedded in a large probiotic trial could provide evidence about which properties of probiotics might be important for NEC prevention thus facilitating identification of strains with therapeutic potential.
Methods:
Intestinal permeability, stool microbiota, SCFAs and mucosal inflammation were assessed from the second postnatal week in babies enrolled to a randomised controlled trial of B. breve BBG-001 (the PiPS trial). Results were compared by allocation and by stool colonisation with the probiotic.
Results:
Ninety-four preterm babies were recruited across six nested studies. B. breve BBG-001 content was higher by allocation and colonisation; Enterobacteriaceae and acetic acid levels were higher by colonisation. No measure of intestinal barrier function showed differences. The PiPS trial found no evidence of efficacy to reduce NEC.
Conclusions:
That the negative results of the PiPS trial were associated with failure of this probiotic to modify intestinal barrier function supports the possibility that the tests described here have the potential to identify strains to progress to large clinical trials.
Impact:
Uncertainty about the therapeutic role of probiotics to prevent necrotising enterocolitis is in part due to the wide range of bacterial strains with no previous evidence of efficacy used in clinical trials. We hypothesised that mechanistic studies embedded in a probiotic trial would provide evidence about which properties of probiotics might be important for NEC prevention. The finding that the probiotic strain tested, Bifidobacterium breve BBG-001, showed neither effects on intestinal barrier function nor clinical efficacy supports the possibility that these tests have the potential to identify strains to progress to large clinical trials.
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