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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
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.
Bach Mai Hospital
Hanoi, Vietnam
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.
Time frame: During four weeks from the date of the site visit to submit a baseline stool sample.
Stool frequency with hard or lumpy one (BS score of 1 or 2)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
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Time frame: 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)
Time frame: During four weeks from the date of the site visit to submit a baseline stool sample.
Chinese Constipation Questionnaire score
Time frame: During four weeks from the date of the site visit to submit a baseline stool sample.
Stool microbiota (increase in the abundance of bifidobacteria)
Time frame: During four weeks from the date of the site visit to submit a baseline stool sample.