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Efficacy Evaluation of Probiotic Product on Bowel Habits in Healthy Subjects

Primary Purpose

Constipation

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Fermented milk containing Lactobacillus casei strain Shirota

Placebo

About this trial

This is an interventional treatment trial for Constipation focused on measuring Hard or lumpy stools, Stool consistency, Stool frequency, Constipation related symptoms, Constipation related quality of life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Harrison Clinical Research Deutschland GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fermented milk

Placebo

Arm Description

Fermented milk containing Lactobacillus casei strain Shirota, 65 ml in a bottle, consume 1 bottle per day.

Non-fermented milk without Lactobacillus casei strain Shirota, 65 ml in a bottle, consume 1 bottle per day.

Outcomes

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

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

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

Spontaneous bowel movement is defined as the bowel movements without laxative use

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.

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.

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.

Full Information

NCT ID

NCT01375712

First Posted

June 15, 2011

Last Updated

January 26, 2012

Sponsor

Yakult Honsha Co., LTD

1. Study Identification

Unique Protocol Identification Number

NCT01375712

Brief Title

Efficacy Evaluation of Probiotic Product on Bowel Habits in Healthy Subjects

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yakult Honsha Co., LTD

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation

Keywords

Hard or lumpy stools, Stool consistency, Stool frequency, Constipation related symptoms, Constipation related quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

238 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fermented milk

Arm Type

Active Comparator

Arm Description

Fermented milk containing Lactobacillus casei strain Shirota, 65 ml in a bottle, consume 1 bottle per day.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Non-fermented milk without Lactobacillus casei strain Shirota, 65 ml in a bottle, consume 1 bottle per day.

Intervention Type

Dietary Supplement

Intervention Name(s)

Fermented milk containing Lactobacillus casei strain Shirota

Other Intervention Name(s)

Commercial name: Yakult

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in the proportion of subjects who produce hard or lumpy stools not less than 25%(≥25%) of weekly number of bowel movements

Description

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.

Time Frame

During pre-treatment (2 weeks) and treatment (8 weeks)

Secondary Outcome Measure Information:

Title

Weekly average Bristol Stool Form Scale score

Description

Time Frame

During pre-treatment (2 weeks) and treatment (8 weeks)

Title

Weekly number of spontaneous bowel movements

Description

Spontaneous bowel movement is defined as the bowel movements without laxative use

Time Frame

During pre-treatment (2 weeks) and treatment (8 weeks)

Title

Weekly number of spontaneous complete bowel movements

Description

Spontaneous complete bowel movement is defined as spontaneous bowel movement relieving the feeling of the presence of stool in the distal bowel.

Time Frame

During pre-treatment (2 weeks) and treatment (8 weeks)

Title

Patient Assessment of Constipation Symptoms (PAC-SYM) score

Description

Time Frame

6 points (Days 1, 15, 29, 43, 57 and 71)

Title

Patient Assessment of Constipation Quality of Life (PAC-QOL) score

Description

Time Frame

6 points (Days 1, 15, 29, 43, 57 and 71)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heiko Ilchmann

Organizational Affiliation

Harrison Clinical Research Deutschland GmbH (Clinical Unit)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Harrison Clinical Research Deutschland GmbH

City

Munich

ZIP/Postal Code

80636

Country

Germany

12. IPD Sharing Statement

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Efficacy Evaluation of Probiotic Product on Bowel Habits in Healthy Subjects

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