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Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 310
Population
A total of 310 patients
Methods
The study aimed to compare the efficacy of inhaled Clostridium butyricum delivered via oxygen-driven nebulization with oral C. butyricum capsules in preventing drug-resistant bacterial pneumonia; 310 patients were randomly assigned to experimental group and control group. In the experimental group, each participant inhaled C. butyricum via oxygen-driven nebulization and orally took a placebo capsule containing glucose powder. In the control group, each participant inhaled sterile water via oxygen-driven nebulization and orally took a C. butyricum capsule daily.
  • Large Human Trial
This study aimed to compare the efficacy of inhaled Clostridium butyricum delivered via oxygen-driven nebulization with oral C. butyricum capsules in preventing drug-resistant bacterial pneumonia, using clinical and microbiological parameters as indicators. A total of 310 patients were randomly assigned to experimental group and control group. In the experimental group, each participant inhaled C. butyricum via oxygen-driven nebulization and orally took a placebo capsule containing glucose powder. In the control group, each participant inhaled sterile water via oxygen-driven nebulization and orally took a C. butyricum capsule daily. Key outcomes included body temperature, white blood cell (WBC) count, high-sensitivity C-reactive protein (hs-CRP) level, chest X ray findings, tracheal tube secretion status, and sputum cultures for Pseudomonas aeruginosa, ESBL-producing Escherichia coli, Staphylococcus aureus and Klebsiella pneumoniae. The incidence of pneumonia was 46.45% (72/155) in the control group, compared to only 1.97% (3/152) in the experimental group (relative risk = 23.54, 95%CI: 7.58-73.08). The experiment group demonstrated significant improvements in clinical parameters, including reduced body temperature, lower WBC counts, and decreased hs-CRP level. Chest X-ray findings and tracheal tube secretion status also improved more markedly in the experiment group. Microbiological analysis revealed a significant reduction in the colonization of pathogenic bacteria in sputum cultures from the experiment group. In conclusion, inhaled C. butyricum delivered via oxygen-driven nebulization appears to be more effective than oral C. butyricum capsules in preventing drug-resistant bacterial pneumonia. These findings suggest that direct delivery of C. butyricum to the respiratory tract via oxygen-driven nebulization may enhance its anti-inflammatory and antimicrobial effects, offering a promising strategy for prevention of drug-resistant bacterial pneumonia. KEY POINTS: • Oxygen-driven nebulization of C. butyricum improved the clinical parameters. • Oxygen-driven nebulization of C. butyricum improved tracheal tube secretion status. • Oxygen-driven nebulization of C. butyricum reduced pathogenic bacteria production.

Research Insights

SupplementDoseHealth OutcomeEffect TypeEffect SizeSource
Clostridium butyricumReduced Incidence of Bacterial PneumoniaBeneficial
Large
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The incidence of pneumonia was 46.45% (72/155) in the control group, compared to only 1.97% (3/152) in the experimental group (relative risk = 23.54, 95%CI: 7.58-73.08).

Clostridium butyricumReduced Pathogenic Bacterial ColonizationBeneficial
Moderate
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Microbiological analysis revealed a significant reduction in the colonization of pathogenic bacteria in sputum cultures from the experiment group.

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