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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Constipation

Intervention / Treatment
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* Dietary Supplement: Lactobacillus casei strain Shirota fermented milk


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fermented milk drink<br> | Dietary Supplement: Lactobacillus casei strain Shirota fermented milk<br>* 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.<br>|
| No Intervention: No drink<br> | |

What is the study measuring?
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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 | Measure Description | 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. |