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

Mena Mustapha Mazlyn, Lee Hun Leong Nagarajah, Arshad Fatimah, Norimah A. Karim, Khean Lee Goh

Research output: Contribution to journalArticle

36 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1141-1147
Number of pages7
JournalJournal of Gastroenterology and Hepatology (Australia)
Volume28
Issue number7
DOIs
Publication statusPublished - 2013

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Probiotics
Constipation
Milk
Placebos
Confidence Intervals
Lactobacillus casei
Healthy Volunteers
Control Groups

Keywords

  • Constipation
  • Lactobacillus casei
  • Probiotics

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology

Cite this

Effects of a probiotic fermented milk on functional constipation : A randomized, double-blind, placebo-controlled study. / Mazlyn, Mena Mustapha; Nagarajah, Lee Hun Leong; Fatimah, Arshad; A. Karim, Norimah; Goh, Khean Lee.

In: Journal of Gastroenterology and Hepatology (Australia), Vol. 28, No. 7, 2013, p. 1141-1147.

Research output: Contribution to journalArticle

Mazlyn, Mena Mustapha ; Nagarajah, Lee Hun Leong ; Fatimah, Arshad ; A. Karim, Norimah ; Goh, Khean Lee. / Effects of a probiotic fermented milk on functional constipation : A randomized, double-blind, placebo-controlled study. In: Journal of Gastroenterology and Hepatology (Australia). 2013 ; Vol. 28, No. 7. pp. 1141-1147.
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N2 - 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.

AB - 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.

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