BACKGROUND AND AIM: Evidence suggests that probiotics reduce certain constipation-related symptoms. Lactobacillus casei strain Shirota has never been tested as treatment for functional constipation in otherwise-healthy subjects. To evaluate the efficacy of this probiotic among adults with functional constipation was aimed. METHODS:Subjects with functional constipation (Rome II-defined) were randomized to intake L. casei strainShirota fermented milk or placebo once daily for 4 weeks under double-blind condition. Primary outcomes were constipation severity and stool frequency; secondary outcomes were stool consistency and quantity. RESULTS: In intent-to-treat population, compared with baseline, constipation severity and stool frequency improved in both probiotic (n = 47) and control groups (n = 43), but improvements were comparable in both groups at week 4 (α = 5% level). In probiotic group, stool consistency and quantity at week 4 improved significantly versus baseline but not versus control. Considering that the study agent is non-pharmaceutical and the purpose of supplementation is for long-term effect, re-evaluation at α = 10% was conducted, which showed significant improvement in constipation severity at week 4 (P = 0.058). Magnitude of the probiotic effect on stool consistency was small but grew over time, d = 0.19, 95% confidence interval 0.00-0.35 (Week 4), d = 0.29, 95% confidence interval 0.11-0.52 (postintervention). Post-hoc exploratory analysis suggests incomplete evacuation may decrease with probiotic intake. CONCLUSIONS: Four-week administration of L. casei strain Shirota did not alleviate constipation severity or stool frequency, consistency, and quantity when compared with control. With re-evaluation at α = 10% level, improvement in constipation severity was significant at week 4. To obtain conclusive results, further studies with longer intervention are warranted.
RCT Entities:
BACKGROUND AND AIM: Evidence suggests that probiotics reduce certain constipation-related symptoms. Lactobacillus casei strain Shirota has never been tested as treatment for functional constipation in otherwise-healthy subjects. To evaluate the efficacy of this probiotic among adults with functional constipation was aimed. METHODS: Subjects with functional constipation (Rome II-defined) were randomized to intake L. casei strain Shirota fermented milk or placebo once daily for 4 weeks under double-blind condition. Primary outcomes were constipation severity and stool frequency; secondary outcomes were stool consistency and quantity. RESULTS: In intent-to-treat population, compared with baseline, constipation severity and stool frequency improved in both probiotic (n = 47) and control groups (n = 43), but improvements were comparable in both groups at week 4 (α = 5% level). In probiotic group, stool consistency and quantity at week 4 improved significantly versus baseline but not versus control. Considering that the study agent is non-pharmaceutical and the purpose of supplementation is for long-term effect, re-evaluation at α = 10% was conducted, which showed significant improvement in constipation severity at week 4 (P = 0.058). Magnitude of the probiotic effect on stool consistency was small but grew over time, d = 0.19, 95% confidence interval 0.00-0.35 (Week 4), d = 0.29, 95% confidence interval 0.11-0.52 (postintervention). Post-hoc exploratory analysis suggests incomplete evacuation may decrease with probiotic intake. CONCLUSIONS: Four-week administration of L. casei strain Shirota did not alleviate constipation severity or stool frequency, consistency, and quantity when compared with control. With re-evaluation at α = 10% level, improvement in constipation severity was significant at week 4. To obtain conclusive results, further studies with longer intervention are warranted.