Constipation
Conditions
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus 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.
Sponsors
Bach Mai Hospital
Vietnam National University
Yakult Honsha Co., LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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 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. |
| 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. |
Other
| Measure | Time frame |
|---|---|
| BS score of the first stool after waking up (descriptive analysis) | During four weeks from the date of the site visit to submit a baseline stool sample. |
Countries
Vietnam
Outcome results
None listed