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J Gastroenterol Hepatol. 2013 Jul;28(7):1141-7. doi: 10.1111/jgh.12168.

Effects of a probiotic fermented milk on functional constipation: a randomized, double-blind, placebo-controlled study.

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  • 1Department of Nutrition and Dietetics, School of Pharmacy and Health Sciences, International Medical University, Kuala Lumpur, Malaysia.

Erratum in

  • J Gastroenterol Hepatol. 2013 Sep;28(9):1584.

Abstract

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.

© 2013 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.

PMID:
23432408
[PubMed - indexed for MEDLINE]
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