Efficacy Evaluation of Probiotic Product on Bowel Habits in Healthy Subjects

Not Applicable

Completed

• Conditions: Constipation
• Interventions: Dietary Supplement: Fermented milk containing Lactobacillus casei strain Shirota; Dietary Supplement: Placebo

• Registration Number: NCT01375712
• Lead Sponsor: Yakult Honsha Co., LTD

Brief 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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-15
• Study First Submitted QC: 2011-06-15
• Study First Posted: 2011-06-17
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-26
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fermented milk	Fermented milk containing Lactobacillus casei strain Shirota	Fermented milk containing Lactobacillus casei strain Shirota, 65 ml in a bottle, consume 1 bottle per day.
Placebo	Placebo	Non-fermented milk without Lactobacillus casei strain Shirota, 65 ml in a bottle, consume 1 bottle per day.

Primary Outcome Measures

Name	Time	Method
Change in the proportion of subjects who produce hard or lumpy stools not less than 25%(≥25%) of weekly number of bowel movements	During pre-treatment (2 weeks) and treatment (8 weeks)	Hard or lumpy stools are defined as stools with Bristol Stool Form Scale score 1 or 2. Incidence of hard or lumpy stools is calculated by weekly basis.

Secondary Outcome Measures

Name	Time	Method
Weekly number of spontaneous bowel movements	During pre-treatment (2 weeks) and treatment (8 weeks)	Spontaneous bowel movement is defined as the bowel movements without laxative use
Weekly average Bristol Stool Form Scale score	During pre-treatment (2 weeks) and treatment (8 weeks)	Bristol Stool Form Scale is a medical aid designed to classify the form of stool with 7 levels; Separate hard lumps like nuts (difficult to pass), score=1; Sausage-shaped but lumpy, score=2;Like a sausage but with cracks on its surface, score=3; Like a sausage or snake, smooth and soft, score=4; Soft blobs with clear-cut edges (passed easily), score=5; Fluffy pieces with ragged edges, a mushy stool, score=6; Watery, no solid pieces, entirely liquid, score=7.
Patient Assessment of Constipation Symptoms (PAC-SYM) score	6 points (Days 1, 15, 29, 43, 57 and 71)	PAC-SYM contains 12 questions which are classified into 3 subdomains (stool symptoms, abdominal symptoms, and rectal symptoms). The average scores of total questionnaires and each subdomain are assessed.
Patient Assessment of Constipation Quality of Life (PAC-QOL) score	6 points (Days 1, 15, 29, 43, 57 and 71)	PAC-QOL contains 28 questions which are classified into 4 subdomains (physical discomfort, worries and concerns, psychosocial discomfort, and satisfaction). The average scores of total questionnaires and each subdomain are assessed.
Weekly number of spontaneous complete bowel movements	During pre-treatment (2 weeks) and treatment (8 weeks)	Spontaneous complete bowel movement is defined as spontaneous bowel movement relieving the feeling of the presence of stool in the distal bowel.

Trial Locations

Locations (1)

Harrison Clinical Research Deutschland GmbH; 🇩🇪 Munich, Germany