Status:
COMPLETED
Lactobacillus Casei Strain Shirota Fermented Milk for Alleviating Hard Stools in Vietnam
Lead Sponsor:
Yakult Honsha Co., LTD
Collaborating Sponsors:
Bach Mai Hospital
Vietnam National University
Conditions:
Constipation
Eligibility:
All Genders
18-60 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2023
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT05982743
Start Date
May 11 2022
End Date
March 8 2023
Last Update
August 14 2023
Active Locations (1)
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1
Bach Mai Hospital
Hanoi, Vietnam, 100000