title: Effects of a probiotic fermented milk on functional constipation: a randomized, double-blind, placebo-controlled study.
abstract: OBJECTIVE
  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.
authors: Department of Nutrition and Dietetics, School of Pharmacy and Health Sciences, International Medical University, Kuala Lumpur, Malaysia.
authors: Mena Mustapha
authors: MM
authors: Mazlyn
authors: Lee Hun-Leong
authors: LH
authors: Nagarajah
authors: Arshad
authors: A
authors: Fatimah
authors: A Karim
authors: AK
authors: Norimah
authors: Khean-Lee
authors: KL
authors: Goh
mesh_terms: D000328:Adult; D003248:Constipation / Q000208:ethnology / Q000628:therapy*; D043302:Cultured Milk Products / Q000382:microbiology; D003672:Defecation / Q000502:physiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007780:Lacticaseibacillus casei / Q000502:physiology*; D008297:Male; D010919:Placebos; D019936:Probiotics / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010919:Placebos