Evaluation of clinical safety and tolerance of a Lactobacillus reuteri NCIMB 30242 supplement capsule: a randomized control trial.
- 2012-07
- Regulatory Toxicology and Pharmacology 63(2)
- M. Jones
- C. Martoni
- E. Di Pietro
- R. Simon
- S. Prakash
- PubMed: 22561556
- DOI: 10.1016/j.yrtph.2012.04.003
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 131
- Population
- Healthy adults
- Methods
- Randomized Controlled Trial
Abstract
A significant number of human clinical trials have reported no adverse effects associated with consumption of Lactobacillus reuteri (L. reuteri). In the present study, the clinical safety and toxicology of oral ingestion of supplement capsules containing L. reuteri NCIMB 30242 was investigated. A randomized group of 131 subjects received a dose of 2.9×10⁹ CFU L. reuteri NCIMB 30242 capsules (n=67) or placebo capsules (n=64) twice daily for 9 weeks. Clinical chemistry and hematological parameters of safety were analyzed. The frequency, duration and intensity of adverse events (AE)s and clinical significance of safety parameters were recorded for both groups. No clinically significant differences between the probiotic capsule and placebo capsule treated groups were detected in either the blood clinical chemistry or hematology results. The frequency and intensity of AEs was similar in the two groups. These results demonstrate that administration of a twice daily dose of 2.9×10⁹ CFU was safe and well tolerated in the population evaluated over 9 weeks.
Trial registration: ClinicalTrials.gov NCT01341613.
Research Insights
No clinically significant differences between the probiotic capsule and placebo capsule treated groups were detected in either the blood clinical chemistry or hematology results.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 2.9×10⁹ CFU twice daily
No clinically significant differences between the probiotic capsule and placebo capsule treated groups were detected in either the blood clinical chemistry or hematology results.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 2.9×10⁹ CFU twice daily
The frequency and intensity of AEs was similar in the two groups.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 2.9×10⁹ CFU twice daily
Adverse Events Reported
No clinically significant differences between the probiotic capsule and placebo capsule treated groups were detected in either the blood clinical chemistry or hematology results.
- Finding
- No significant difference
- Significant
- No
These results demonstrate that administration of a twice daily dose of 2.9×10⁹ CFU was safe and well tolerated in the population evaluated over 9 weeks.
- Finding
- Reported