PRIMAL
Trial question
What is the role of multistrain probiotics in gut dysbiosis in preterm infants?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
46.0% female
54.0% male
N = 618
618 patients (285 female, 333 male).
Inclusion criteria: infants with gestational age of 28-32 weeks at neonatal units.
Key exclusion criteria: infants with malformations that are not compatible with survival beyond the first 48 hours of life or that severely affect the gastrointestinal tract.
Interventions
N=306 probiotics (Bifidobacterium infantis, Bifidobacterium lactis, L. acidophilus in the first 28 days of life).
N=312 placebo (cornstarch powder of similar color and odor as verum in the first 28 days of life).
Primary outcome
Colonization with multidrug-resistant organisms or highly epidemic bacteria at day 30 of life, interim analysis
37.4%
37.5%
37.5 %
28.1 %
18.8 %
9.4 %
0.0 %
Probiotics
Placebo
No significant
difference ↔
No significant difference in colonization with multidrug-resistant organisms or highly epidemic bacteria at day 30 of life, interim analysis (37.4% vs. 37.5%; RR 0.99, 99% CI 0.54 to 1.81).
Secondary outcomes
No significant difference in colonization with multidrug-resistant organisms or highly epidemic bacteria at day 30 of life, all infants (34.6% vs. 37.8%; OR 0.87, 95% CI 0.59 to 1.28).
Significant increase in eubiosis classification at bacterial genus resolution (55.9% vs. 44.2%; OR 1.61, 95% CI 1.12 to 2.31).
Significant increase in median eubiosis model score at bacterial genus resolution (0.47 points vs. 0.41 points; OR 1.07, 95% CI 1.02 to 1.13).
Safety outcomes
No significant difference in blood culture-proven sepsis and severe gastrointestinal complications.
Conclusion
In infants with gestational age of 28-32 weeks at neonatal units, probiotics were not superior to placebo with respect to colonization with multidrug-resistant organisms or highly epidemic bacteria at day 30 of life, interim analysis.
Reference
Thea Van Rossum, Annette Haiß, Rebecca L Knoll et al. Bifidobacterium and Lactobacillus Probiotics and Gut Dysbiosis in Preterm Infants: The PRIMAL Randomized Clinical Trial. JAMA Pediatr. 2024 Aug 5.
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