Lactobacillus Casei Strain Shirota Fermented Milk for Alleviating Hard Stools in Vietnam
Not Applicable
Completed
- Conditions
- Constipation
- Interventions
- Dietary Supplement: Lactobacillus casei strain Shirota fermented milk
- Registration Number
- NCT05982743
- Lead Sponsor
- Yakult Honsha Co., LTD
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fermented milk drink Lactobacillus casei strain Shirota fermented milk -
- Primary Outcome Measures
Name Time Method Proportion of subjects that produce hard or lumpy stools (Bristol stool form scale (BS) score of 1 or 2) ≥ 25% of bowel movements 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
Name Time Method 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.
Trial Locations
- Locations (1)
Bach Mai Hospital
🇻🇳Hanoi, Vietnam