Lactobacillus Casei Strain Shirota Fermented Milk for Alleviating Hard Stools in Vietnam
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ClinicalTrials.gov Identifier: NCT05982743 |
Recruitment Status :
Completed
First Posted : August 9, 2023
Last Update Posted : August 14, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Constipation | Dietary Supplement: Lactobacillus casei strain Shirota fermented milk | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 51 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | May 11, 2022 |
Actual Primary Completion Date : | March 8, 2023 |
Actual Study Completion Date : | March 8, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Fermented milk drink |
Dietary Supplement: Lactobacillus 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. |
No Intervention: No drink |
- Proportion of subjects that produce hard or lumpy stools (Bristol stool form scale (BS) score of 1 or 2) ≥ 25% of bowel movements [ Time Frame: 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.
- 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) [ 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. ]
- BS score of the first stool after waking up (descriptive analysis) [ Time Frame: During four weeks from the date of the site visit to submit a baseline stool sample. ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05982743
Vietnam | |
Bach Mai Hospital | |
Hanoi, Vietnam, 100000 |
Principal Investigator: | Vinh Van Hoang, PhD | Vietnam National University |
Responsible Party: | Yakult Honsha Co., LTD |
ClinicalTrials.gov Identifier: | NCT05982743 |
Other Study ID Numbers: |
YAK-VN-001 |
First Posted: | August 9, 2023 Key Record Dates |
Last Update Posted: | August 14, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Constipation Signs and Symptoms, Digestive |