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

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

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Dietary supplement: Lactobacillus casei strain Shirota fermented milk

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam, 100000
    • Bach Mai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fermented milk drink	Dietary supplement: Lactobacillus casei strain Shirota fermented milk; 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.
No Intervention: No drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During four weeks from the date of the site visit to submit a baseline stool sample.

Secondary Outcome Measures

Outcome Measure	Time Frame
Stool frequency with hard or lumpy one (BS score of 1 or 2)	During four weeks from the date of the site visit to submit a baseline stool sample.
Stool frequency with ideal stool (BS score of 4)	During four weeks from the date of the site visit to submit a baseline stool sample.
Stool frequency, as measured by a daily stool diary	During four weeks from the date of the site visit to submit a baseline stool sample.
Stool frequency with straining during evacuation, as measured by a daily stool diary (Yes/No)	During four weeks from the date of the site visit to submit a baseline stool sample.
Stool frequency with sensation of remaining stool in the rectum after the evacuation, as measured by a daily stool diary (Yes/No)	During four weeks from the date of the site visit to submit a baseline stool sample.
Stool frequency with sensation of anorectal blockage, as measured by a daily stool diary (Yes/No)	During four weeks from the date of the site visit to submit a baseline stool sample.
Stool frequency with which manual maneuvers are used, as measured by a daily stool diary (Yes/No)	During four weeks from the date of the site visit to submit a baseline stool sample.
Chinese Constipation Questionnaire score	During four weeks from the date of the site visit to submit a baseline stool sample.
Stool microbiota (increase in the abundance of bifidobacteria)	During four weeks from the date of the site visit to submit a baseline stool sample.

Other Outcome Measures

Outcome Measure	Time Frame
BS score of the first stool after waking up (descriptive analysis)	During four weeks from the date of the site visit to submit a baseline stool sample.

Collaborators and Investigators

• Sponsor: Yakult Honsha Co., LTD
• Collaborators: Vietnam National University; Bach Mai Hospital
• Investigators: Principal Investigator: Vinh Van Hoang, PhD, Vietnam National University

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2022
• Primary Completion (Actual): March 8, 2023
• Study Completion (Actual): March 8, 2023

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: YAK-VN-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No