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

NCT ID: NCT05982743

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-11
• Study Completion Date: 2023-03-08

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.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fermented milk drink

Group Type: EXPERIMENTAL

Lactobacillus casei strain Shirota fermented milk

Intervention Type: DIETARY_SUPPLEMENT

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 drink

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bach Mai Hospital

OTHER

Sponsor Role: collaborator

Vietnam National University

OTHER

Sponsor Role: collaborator

Yakult Honsha Co., LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vinh Van Hoang, PhD

Role: PRINCIPAL_INVESTIGATOR

Vietnam National University

Locations

Bach Mai Hospital

Hanoi, , Vietnam

Countries

Vietnam

Other Identifiers

YAK-VN-001

Identifier Type: -

Identifier Source: org_study_id