Efficacy Evaluation of Probiotic Product on Bowel Habits in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yakult Honsha Co., LTD
ClinicalTrials.gov Identifier:
NCT01375712
First received: June 15, 2011
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Constipation
Dietary Supplement: Fermented milk containing Lactobacillus casei strain Shirota
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Yakult Honsha Co., LTD:

Primary Outcome Measures:
  • Change in the proportion of subjects who produce hard or lumpy stools not less than 25%(≥25%) of weekly number of bowel movements [ Time Frame: During pre-treatment (2 weeks) and treatment (8 weeks) ] [ Designated as safety issue: No ]
    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:
  • Weekly average Bristol Stool Form Scale score [ Time Frame: During pre-treatment (2 weeks) and treatment (8 weeks) ] [ Designated as safety issue: No ]
    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.

  • Weekly number of spontaneous bowel movements [ Time Frame: During pre-treatment (2 weeks) and treatment (8 weeks) ] [ Designated as safety issue: No ]
    Spontaneous bowel movement is defined as the bowel movements without laxative use

  • Weekly number of spontaneous complete bowel movements [ Time Frame: During pre-treatment (2 weeks) and treatment (8 weeks) ] [ Designated as safety issue: No ]
    Spontaneous complete bowel movement is defined as spontaneous bowel movement relieving the feeling of the presence of stool in the distal bowel.

  • Patient Assessment of Constipation Symptoms (PAC-SYM) score [ Time Frame: 6 points (Days 1, 15, 29, 43, 57 and 71) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 points (Days 1, 15, 29, 43, 57 and 71) ] [ Designated as safety issue: No ]
    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.


Enrollment: 238
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375712

Locations
Germany
Harrison Clinical Research Deutschland GmbH
Munich, Germany, 80636
Sponsors and Collaborators
Yakult Honsha Co., LTD
Investigators
Principal Investigator: Heiko Ilchmann Harrison Clinical Research Deutschland GmbH (Clinical Unit)
  More Information

No publications provided

Responsible Party: Yakult Honsha Co., LTD
ClinicalTrials.gov Identifier: NCT01375712     History of Changes
Other Study ID Numbers: YAK_BSFS
Study First Received: June 15, 2011
Last Updated: January 26, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Yakult Honsha Co., LTD:
Hard or lumpy stools
Stool consistency
Stool frequency
Constipation related symptoms
Constipation related quality of life

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014