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Efficacy of Lactobacillus casei Shirota for patients with irritable bowel syndrome.

  • 2016-01
  • European journal of gastroenterology & hepatology 28(1)
    • Annemieke Y Thijssen
    • Cees H M Clemens
    • Vanessa Vankerckhoven
    • Herman Goossens
    • Daisy M A E Jonkers
    • Ad A M Masclee

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 41
Population
IBS patients (Rome II) between 18 and 65 years of age
Methods
randomized, double-blind, placebo-controlled intervention study; 8-week intervention period receiving probiotic (LcS) or placebo twice daily, followed by 8-week follow-up period
Blinding
Double-blind
Duration
8 weeks
Funding
Unclear

Background and aims

Meta-analyses point to a modest but significant effect of probiotics on symptoms in irritable bowel syndrome (IBS). We aimed to assess the effect of the probiotic Lactobacillus casei Shirota (LcS) on symptoms and quality of life in IBS patients in a randomized, double-blind, placebo-controlled intervention study.

Materials and methods

IBS patients (Rome II) between 18 and 65 years of age were included. The study consisted of an 8-week intervention period in which the participants received probiotic (LcS) or placebo twice daily, followed by an 8-week follow-up period. Symptom diaries and quality of life were scored at weeks 0, 8 and 16. The primary outcome parameter was a decrease of at least 30% in a composite mean symptom score (MSS) at week 8 on the basis of an intention-to-treat analysis.

Results

Thirty-nine individuals (67% women) were included in the probiotic group and 41 individuals (71% women) were included in the placebo group. After the intervention period, the mean relative improvement did not reach 30% for MSS or any individual symptom score. After follow-up (week 16), a mean improvement of at least 30% was achieved for MSS in the probiotic group, but no significant difference was found between both treatment groups (mean±SD: 34±7%; 13±8%, P=0.06).

Conclusion

After probiotic treatment with LcS, no improvement of 30% in MSS was observed after 8 weeks.

Research Insights

  • Lacticaseibacillus casei→Improved Composite Symptom Score

    After the intervention period, the mean relative improvement did not reach 30% for MSS or any individual symptom score. After follow-up (week 16), a mean improvement of at least 30% was achieved for MSS in the probiotic group, but no significant difference was found between both treatment groups (mean±SD: 34±7%; 13±8%, P=0.06).

    Effect
    Neutral
    Effect size
    Small
    Dose
    twice daily
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