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Lactobacillus acidophilus for infant colic and microbiota modulation: a randomized clinical trial.

  • 2026-04-18
  • BMC pediatrics 26(1)
    • Sáskia Ribeiro Vaz
    • Marise Helena Cardoso Tofoli
    • Melissa Ameloti Gomes Avelino
    • João Felipe Mota
    • Humberto Bezerra de Araujo Filho
    • Paulo Sucasas da Costa

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 60
Population
60 infants with colic
Methods
Double-blind, placebo-controlled randomized trial, 28 days of L. acidophilus NCFM 1×10^9 CFU or placebo
Blinding
Double-blind
Duration
28 days
Funding
Unclear
BACKGROUND: Infantile colic affects up to 25% of infants during the early weeks of life. Dysbiosis plays a prominent role in its pathogenesis, supporting the potential therapeutic role of probiotics. We aimed to evaluate the efficacy of Lactobacillus acidophilus NCFM versus placebo in infant colic and microbiota modulation. METHODS: A double-blind, placebo-controlled randomized trial was conducted with 60 infants with colic, randomly assigned to receive five drops of L. acidophilus NCFM (1 × 109 CFU) or placebo for 28 days. Data on responders (subjects with a colicky full-force crying/fussing time reduction of ≥ 50% from baseline), daily fussing and crying time, adverse effects, and maternal and child characteristics were collected. Changes in gut microbiota and fecal calprotectin were also evaluated. The study was registered at ensaiosclinicos.gov.br (RBR-5pp4nks). RESULTS: The primary endpoint (proportion of responders at Day 28) was not significantly different between groups (p = 0.240). A higher responder rate was observed in the intervention group at Day 14 in exploratory analyses (p = 0.045); however, this result was attenuated after correction for multiple comparisons. No statistical difference was observed in calprotectin concentration (p = 0.687), infant mood (p = 0.720), fussing and crying time (p = 0.524). A higher diversity was observed in the breastfed and formula-fed groups utilizing probiotics, but not in the formula-fed group receiving placebo. A high relative abundance of Akkermansia was identified in the probiotic group. Ruminococcus was identified in both groups before and after the intervention. CONCLUSIONS: Intervention did not significantly improve the proportion of responders at Day 28, the primary endpoint. An apparent benefit at Day 14 emerged in secondary. The use of L. acidophilus NCFM was able to improve some aspects of infants’ intestinal microbiota. Also, there was no statistical difference in calprotectin and infant mood. The use of L. acidophilus NCFM was safe for this population. CLINICAL TRIAL REGISTRATION: The study was registered at ensaiosclinicos.gov.br (RBR-5pp4nks), retrospectively registered at 09/09/2023.

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