Clinical trial NCT05982743: Lactobacillus Casei Strain Shirota Fermented Milk for Alleviating Hard Stools in Vietnam
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Lead sponsor: Yakult Honsha Co., LTD
Sponsor class: INDUSTRY
Collaborators: name: Bach Mai Hospital
name: Vietnam National University
First posted: 2023-08-09
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of subjects that produce hard or lumpy stools (Bristol stool form scale (BS) score of 1 or 2) ≥ 25% of bowel movements
timeFrame: During four weeks from the date of the site visit to submit a baseline stool sample.
Secondary outcomes:
measure: Stool frequency with hard or lumpy one (BS score of 1 or 2)
timeFrame: During four weeks from the date of the site visit to submit a baseline stool sample.
measure: Stool frequency with ideal stool (BS score of 4)
timeFrame: During four weeks from the date of the site visit to submit a baseline stool sample.
measure: Stool frequency, as measured by a daily stool diary
timeFrame: During four weeks from the date of the site visit to submit a baseline stool sample.
measure: Stool frequency with straining during evacuation, as measured by a daily stool diary (Yes/No)
timeFrame: During four weeks from the date of the site visit to submit a baseline stool sample.
measure: Stool frequency with sensation of remaining stool in the rectum after the evacuation, as measured by a daily stool diary (Yes/No)
timeFrame: During four weeks from the date of the site visit to submit a baseline stool sample.
measure: Stool frequency with sensation of anorectal blockage, as measured by a daily stool diary (Yes/No)
timeFrame: During four weeks from the date of the site visit to submit a baseline stool sample.
measure: Stool frequency with which manual maneuvers are used, as measured by a daily stool diary (Yes/No)
timeFrame: During four weeks from the date of the site visit to submit a baseline stool sample.
measure: Chinese Constipation Questionnaire score
timeFrame: During four weeks from the date of the site visit to submit a baseline stool sample.
measure: Stool microbiota (increase in the abundance of bifidobacteria)
timeFrame: During four weeks from the date of the site visit to submit a baseline stool sample.
Other outcomes:
measure: BS score of the first stool after waking up (descriptive analysis)
timeFrame: During four weeks from the date of the site visit to submit a baseline stool sample.
Locations:
city: Hanoi
country: Vietnam
facility: Bach Mai Hospital
Study officials:
affiliation: Vietnam National University
name: Vinh Van Hoang, PhD
role: PRINCIPAL_INVESTIGATOR
References: