Efficacy Evaluation of Probiotic Product on Bowel Habits in Healthy Subjects

Evaluation of the Impact of a Fermented Milk Containing Lactobacillus Casei Strain Shirota on Stool Consistency, Stool Frequency, Constipation-related Symptoms and Quality of Life in People Who Frequently Have Hard or Lumpy Stools

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Dietary supplement: Fermented milk containing Lactobacillus casei strain Shirota; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 238
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 80636
    • Harrison Clinical Research Deutschland GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria; a subject:

• is informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed, and give written consent to participate in the study prior to the start of any study-related procedures
• is healthy female or male, 18-65 years of age, inclusive
• is conscious of having hard or lumpy stools in daily life
• has an average Bristol Stool Form Scale score <3.0 per bowel movement
• female subjects of childbearing potential should use a reliable method of contraception

Exclusion Criteria; a subject:

• is under the age of legal consent
• is mentally or legally incapacitated
• is treated by a doctor for her/his constipation
• has a history of gastrointestinal surgery except for appendectomy
• has a history of chronic gastrointestinal diseases, including but not limited to inflammatory bowel diseases
• has a severe gastrointestinal disorder
• has clinically relevant medical conditions, e.g., renal, hepatic, pulmonary, cardiac, hematological, endocrinological, neurological, or psychiatric conditions
• is pregnant or wanting to become pregnant during the course of the study
• is unable to refrain from or anticipates the use of any medication (including laxatives, diuretics, prescription and non-prescription drugs, vitamins and herbal supplements), except for paracetamol, oral contraceptives, or hormonal replacement therapy during the screening visit and for the duration of the study
• has a history of drug and/or alcohol abuse
• has milk allergies
• is intolerant to lactose

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fermented milk; Fermented milk containing Lactobacillus casei strain Shirota, 65 ml in a bottle, consume 1 bottle per day.	Dietary supplement: Fermented milk containing Lactobacillus casei strain Shirota; 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.; Other Names: Commercial name: Yakult
Placebo Comparator: Placebo; Non-fermented milk without Lactobacillus casei strain Shirota, 65 ml in a bottle, consume 1 bottle per day.	Dietary supplement: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the proportion of subjects who produce hard or lumpy stools not less than 25%(≥25%) of weekly number of bowel movements	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.	During pre-treatment (2 weeks) and treatment (8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly average Bristol Stool Form Scale score	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.	During pre-treatment (2 weeks) and treatment (8 weeks)
Weekly number of spontaneous bowel movements	Spontaneous bowel movement is defined as the bowel movements without laxative use	During pre-treatment (2 weeks) and treatment (8 weeks)
Weekly number of spontaneous complete bowel movements	Spontaneous complete bowel movement is defined as spontaneous bowel movement relieving the feeling of the presence of stool in the distal bowel.	During pre-treatment (2 weeks) and treatment (8 weeks)
Patient Assessment of Constipation Symptoms (PAC-SYM) score	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.	6 points (Days 1, 15, 29, 43, 57 and 71)
Patient Assessment of Constipation Quality of Life (PAC-QOL) score	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.	6 points (Days 1, 15, 29, 43, 57 and 71)

Collaborators and Investigators

• Sponsor: Yakult Honsha Co., LTD
• Investigators: Principal Investigator: Heiko Ilchmann, Harrison Clinical Research Deutschland GmbH (Clinical Unit)

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: June 15, 2011
• First Submitted That Met QC Criteria: June 15, 2011
• First Posted (Estimate): June 17, 2011

Study Record Updates

• Last Update Posted (Estimate): January 31, 2012
• Last Update Submitted That Met QC Criteria: January 26, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Stool frequency; Hard or lumpy stools; Stool consistency; Constipation related symptoms; Constipation related quality of life
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: YAK_BSFS