Efficacy Evaluation of Probiotic Product on Bowel Habits in Healthy Subjects

January 26, 2012 updated by: Yakult Honsha Co., LTD

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
238

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 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.
During pre-treatment (2 weeks) and treatment (8 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weekly average Bristol Stool Form Scale score
Time Frame: 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.
During pre-treatment (2 weeks) and treatment (8 weeks)
Weekly number of spontaneous bowel movements
Time Frame: During pre-treatment (2 weeks) and treatment (8 weeks)
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
Time Frame: 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.
During pre-treatment (2 weeks) and treatment (8 weeks)
Patient Assessment of Constipation Symptoms (PAC-SYM) score
Time Frame: 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.
6 points (Days 1, 15, 29, 43, 57 and 71)
Patient Assessment of Constipation Quality of Life (PAC-QOL) score
Time Frame: 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.
6 points (Days 1, 15, 29, 43, 57 and 71)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yakult Honsha Co., LTD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heiko Ilchmann, Harrison Clinical Research Deutschland GmbH (Clinical Unit)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YAK_BSFS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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