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

• ClinicalTrials.gov Identifier: NCT05982743
• Recruitment Status: Completed
• First Posted: August 9, 2023
• Last Update Posted: August 14, 2023
• Sponsor: Yakult Honsha Co., LTD
• Collaborators: Bach Mai Hospital; Vietnam National University
• Information provided by (Responsible Party): Yakult Honsha Co., LTD

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.

Condition or disease	Intervention/treatment	Phase
Constipation	Dietary Supplement: Lactobacillus casei strain Shirota fermented milk	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 11, 2022
• Actual Primary Completion Date: March 8, 2023
• Actual Study Completion Date: March 8, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Proportion of subjects that produce hard or lumpy stools (Bristol stool form scale (BS) score of 1 or 2) ≥ 25% of bowel movements [ Time Frame: During four weeks from the date of the site visit to submit a baseline stool sample. ]
   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 :

1. 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. ]
2. 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. ]
3. 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. ]
4. 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. ]
5. 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. ]
6. 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. ]
7. 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. ]
8. Chinese Constipation Questionnaire score [ Time Frame: During four weeks from the date of the site visit to submit a baseline stool sample. ]
9. 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 Outcome Measures:

1. 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. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Vietnam

Bach Mai Hospital

Hanoi, Vietnam, 100000

Sponsors and Collaborators

Yakult Honsha Co., LTD

Bach Mai Hospital

Vietnam National University

Investigators

• Principal Investigator: Vinh Van Hoang, PhD; Vietnam National University

More Information

• Responsible Party: Yakult Honsha Co., LTD
• ClinicalTrials.gov Identifier: NCT05982743
• Other Study ID Numbers: YAK-VN-001
• First Posted: August 9, 2023
• Last Update Posted: August 14, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Constipation; Signs and Symptoms, Digestive