Efficacy Evaluation of Probiotic Product on Bowel Habits in Healthy Subjects
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The objective of this study is to evaluate if consumption of fermented milk containing
      Lactobacillus casei strain Shirota has an impact on stool consistency, stool frequency,
      constipation-related symptoms, and quality of life in subjects who frequently have hard or
      lumpy stools.
    

Detailed description: 
      Constipation is a common problem affecting approximately 17% of the general population in
      Europe. Several reports suggest that production of hard or lumpy stools (HLS) is strongly
      associated with the development of constipation. HLS are produced not only by chronic
      constipated patient but also by healthy population. Thus, reducing the incidence of HLS might
      be beneficial in terms of reducing the incidence of constipation in healthy population.

      The results of two clinical studies conducted in Europe indicate the positive effect of
      fermented milk (FM) containing Lactobacillus casei strain Shirota (LcS) to modulate the
      hardness or dryness of stools. Koebnick et al. (2003) reported that consumption of the FM
      drink containing LcS decreased the occurrence of hard or lumpy stools, and improved the
      severity of constipation in patients with chronic constipation in Germany. An open trial
      conducted in Ghent, Belgium used commercially available FM containing LcS (Yakult® Light) in
      subjects who frequently had hard or lumpy stools, screened by an average Bristol Stool Form
      Scale (BS) score < 3.0. After 3 weeks of treatment, the proportion of subjects who produced
      hard or lumpy stools (BS score = 1 or 2) ≥ 25% of bowel movements decreased from 73.7% at
      baseline to 36.8%, while in the non-intervention control group the proportion increased from
      75.0% to 85.0% during the same period. Based on the results of those studies, it was
      anticipated that LcS might assist in reducing the production of hard or lumpy stools in the
      general population. In order to confirm the efficacy in healthy population, a randomised,
      double blind, placebo control study is required.
    

Intervention name(s): Fermented milk containing Lactobacillus casei strain Shirota; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A fermented milk containing Lactobacillus casei strain Shirota, 65 ml for oral administration, 1 bottle per day for 8 weeks (56 days). One bottle of the drink contains: 42.9 kcal/182 kJ; less than 0.1 g of fat; 9.6 g of carbohydrate; 0.01 g of sodium; 0.9 g of protein; and at least 6.5 x 10^9 colony-forming units of Lactobacillus casei strain Shirota.; Non-fermented milk without Lactobacillus casei strain Shirota, 65 ml for oral administration, 1 bottle per day for 8 weeks (56 days). One bottle of the drink contains: 42.9 kcal/182 kJ; less than 0.1 g of fat; 9.6 g of carbohydrate; 0.01 g of sodium; and 0.9 g of protein.
Other intervention name(s): Commercial name: Yakult
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hard or lumpy stools; Stool consistency; Stool frequency; Constipation related symptoms; Constipation related quality of life