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Lactobacillus Casei Strain Shirota Fermented Milk for Alleviating Hard Stools in Vietnam

Primary Purpose

Constipation

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Lactobacillus casei strain Shirota fermented milk
Sponsored by
Yakult Honsha Co., LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Female or male, aged between 18 to 60 years. Aware of producing hard or lumpy stools (BS score of 1 or 2) frequently. Produce hard or lumpy stools (BS score of 1 or 2) ≥ 25% of bowel movements during 2 weeks of screening period. Voluntarily provide written informed consent to participate in the study. Exclusion Criteria: Subjects whose constipation symptoms are caused by primary organic disease of the colon or pelvic floora or which, in the Investigator's opinion, is caused by medication (e.g. morphine, codeine). Subjects with metabolic disorders, neurological disorders or any significant diseases or concomitant condition (e.g. abdominal/gastrointestinal surgery) that, in the investigator's opinion, would interfere with participation in the study. Subjects with any known allergic reactions to any ingredients of milk. Pregnant or nursing (breast-feeding) women. Subjects who are unable to refrain from or anticipate 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 from 2-week before the initiation of screening of subject BS score to the end of the study. Subjects who are unable to refrain from or anticipate the use of any probiotics, prebiotics or yogurts from 2-week before the initiation of screening of subject BS score to the end of the study. Participation in another study with Investigational product within 2 months prior to this study. Drug or alcohol abuse.

Sites / Locations

  • Bach Mai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fermented milk drink

No drink

Arm Description

Outcomes

Primary Outcome Measures

Proportion of subjects that produce hard or lumpy stools (Bristol stool form scale (BS) score of 1 or 2) ≥ 25% of bowel movements
Overall treatment effect during the intervention period will be estimated using mixed effects logistic regression (with a random intercept) which include "Groups (Yakult/non-treatment)", "Weeks (first/second two weeks of the intervention period)", "baseline (median BS score during baseline)" and "Gender (women/men)" as the independent variables. "Groups x Weeks" interaction will not be included because it was absent in the past RCT studies giving Yakult.

Secondary Outcome Measures

Stool frequency with hard or lumpy one (BS score of 1 or 2)
Stool frequency with ideal stool (BS score of 4)
Stool frequency, as measured by a daily stool diary
Stool frequency with straining during evacuation, as measured by a daily stool diary (Yes/No)
Stool frequency with sensation of remaining stool in the rectum after the evacuation, as measured by a daily stool diary (Yes/No)
Stool frequency with sensation of anorectal blockage, as measured by a daily stool diary (Yes/No)
Stool frequency with which manual maneuvers are used, as measured by a daily stool diary (Yes/No)
Chinese Constipation Questionnaire score
Stool microbiota (increase in the abundance of bifidobacteria)

Full Information

First Posted
July 20, 2023
Last Updated
August 9, 2023
Sponsor
Yakult Honsha Co., LTD
Collaborators
Bach Mai Hospital, Vietnam National University
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1. Study Identification

Unique Protocol Identification Number
NCT05982743
Brief Title
Lactobacillus Casei Strain Shirota Fermented Milk for Alleviating Hard Stools in Vietnam
Official Title
A Pilot Study of Using Fermented Milk Containing Lactobacillus Casei Strain Shirota (LcS) in Some Constipated Adults Having High Prevalence of Hard Stools in Vietnam
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
March 8, 2023 (Actual)
Study Completion Date
March 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yakult Honsha Co., LTD
Collaborators
Bach Mai Hospital, Vietnam National University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to provide evidence supporting the efficacy of fermented milk containing Lactobacillus casei strain Shirota in alleviating hard or lumpy stools. A randomized, controlled trial has been designed on constipated adults with a high prevalence of hard stools in Vietnam.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fermented milk drink
Arm Type
Experimental
Arm Title
No drink
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus casei strain Shirota fermented milk
Intervention Description
Participants will take one bottle (65 ml) of Yakult® drink daily, containing at least 6.5 x 10^9 CFU of Lactobacillus casei strain Shirota, for a period of 4 weeks. Subsequently, there will be a two-week follow-up period.
Primary Outcome Measure Information:
Title
Proportion of subjects that produce hard or lumpy stools (Bristol stool form scale (BS) score of 1 or 2) ≥ 25% of bowel movements
Description
Overall treatment effect during the intervention period will be estimated using mixed effects logistic regression (with a random intercept) which include "Groups (Yakult/non-treatment)", "Weeks (first/second two weeks of the intervention period)", "baseline (median BS score during baseline)" and "Gender (women/men)" as the independent variables. "Groups x Weeks" interaction will not be included because it was absent in the past RCT studies giving Yakult.
Time Frame
During four weeks from the date of the site visit to submit a baseline stool sample.
Secondary Outcome Measure Information:
Title
Stool frequency with hard or lumpy one (BS score of 1 or 2)
Time Frame
During four weeks from the date of the site visit to submit a baseline stool sample.
Title
Stool frequency with ideal stool (BS score of 4)
Time Frame
During four weeks from the date of the site visit to submit a baseline stool sample.
Title
Stool frequency, as measured by a daily stool diary
Time Frame
During four weeks from the date of the site visit to submit a baseline stool sample.
Title
Stool frequency with straining during evacuation, as measured by a daily stool diary (Yes/No)
Time Frame
During four weeks from the date of the site visit to submit a baseline stool sample.
Title
Stool frequency with sensation of remaining stool in the rectum after the evacuation, as measured by a daily stool diary (Yes/No)
Time Frame
During four weeks from the date of the site visit to submit a baseline stool sample.
Title
Stool frequency with sensation of anorectal blockage, as measured by a daily stool diary (Yes/No)
Time Frame
During four weeks from the date of the site visit to submit a baseline stool sample.
Title
Stool frequency with which manual maneuvers are used, as measured by a daily stool diary (Yes/No)
Time Frame
During four weeks from the date of the site visit to submit a baseline stool sample.
Title
Chinese Constipation Questionnaire score
Time Frame
During four weeks from the date of the site visit to submit a baseline stool sample.
Title
Stool microbiota (increase in the abundance of bifidobacteria)
Time Frame
During four weeks from the date of the site visit to submit a baseline stool sample.
Other Pre-specified Outcome Measures:
Title
BS score of the first stool after waking up (descriptive analysis)
Time Frame
During four weeks from the date of the site visit to submit a baseline stool sample.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female or male, aged between 18 to 60 years. Aware of producing hard or lumpy stools (BS score of 1 or 2) frequently. Produce hard or lumpy stools (BS score of 1 or 2) ≥ 25% of bowel movements during 2 weeks of screening period. Voluntarily provide written informed consent to participate in the study. Exclusion Criteria: Subjects whose constipation symptoms are caused by primary organic disease of the colon or pelvic floora or which, in the Investigator's opinion, is caused by medication (e.g. morphine, codeine). Subjects with metabolic disorders, neurological disorders or any significant diseases or concomitant condition (e.g. abdominal/gastrointestinal surgery) that, in the investigator's opinion, would interfere with participation in the study. Subjects with any known allergic reactions to any ingredients of milk. Pregnant or nursing (breast-feeding) women. Subjects who are unable to refrain from or anticipate 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 from 2-week before the initiation of screening of subject BS score to the end of the study. Subjects who are unable to refrain from or anticipate the use of any probiotics, prebiotics or yogurts from 2-week before the initiation of screening of subject BS score to the end of the study. Participation in another study with Investigational product within 2 months prior to this study. Drug or alcohol abuse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vinh Van Hoang, PhD
Organizational Affiliation
Vietnam National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bach Mai Hospital
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No

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Lactobacillus Casei Strain Shirota Fermented Milk for Alleviating Hard Stools in Vietnam

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