ConstipationNCT05982743
Lactobacillus Casei Strain Shirota Fermented Milk for Alleviating Hard Stools in Vietnam
A study testing Lactobacillus casei strain Shirota fermented milk in people with Constipation, run by Yakult Honsha Co., LTD at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Lactobacillus casei strain Shirota fermented milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteVietnam
- Study dates
- 11 May 2022to 8 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Constipation
- Being tested
- Lactobacillus casei strain Shirota fermented milk
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus casei strain Shirota fermented milkDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Fermented milk drink | Experimental | Not described Receives: Dietary Supplement: Lactobacillus casei strain Shirota fermented milk |
| No drink | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During four weeks from the date of the site visit to submit a baseline stool sample.
Secondary outcomes (9)
Stool frequency with hard or lumpy one (BS score of 1 or 2)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: During four weeks from the date of the site visit to submit a baseline stool sample.
Chinese Constipation Questionnaire score
Measured: During four weeks from the date of the site visit to submit a baseline stool sample.
Stool microbiota (increase in the abundance of bifidobacteria)
Measured: During four weeks from the date of the site visit to submit a baseline stool sample.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start11 May 2022
- Primary completion8 Mar 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yakult Honsha Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bach Mai Hospital, Vietnam National University
- Responsible party
- Sponsor
- Investigators
- Vinh Van Hoang, PhD, Principal investigator, Vietnam National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982743
- Sponsor's protocol ID
- YAK-VN-001
- Status last verified
- Jul 2023
- First submitted
- 20 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoang Van V, Dong Van T, Nguyen Bao N, Nguyen Quynh U, Nguyen Thi Linh C, Dao Xuan C, Akiyama T. Effects of fermented milk containing Lacticaseibacillus paracasei strain Shirota on constipation and gut microbiota: A randomised pilot study in Vietnam. Benef Microbes. 2026 Apr 13:1-14. doi: 10.1163/18762891-bja00116. Online ahead of print.
PubMed 41980711
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05982743
- Acronym / sponsor ID
- YAK-VN-001
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Yakult Honsha Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Bach Mai Hospital, Vietnam National University
- Study start
- 11 May 2022 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fermented milk drink | Experimental | Dietary Supplement: Lactobacillus casei strain Shirota fermented milk |
| No drink | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus casei strain Shirota fermented milkParticipants 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. | Dietary supplement | Fermented milk drink |
Primary outcome
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.
9 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 41980711Hoang Van V, Dong Van T, Nguyen Bao N, Nguyen Quynh U, Nguyen Thi Linh C, Dao Xuan C, Akiyama T. Effects of fermented milk containing Lacticaseibacillus paracasei strain Shirota on constipation and gut microbiota: A randomised pilot study in Vietnam. Benef Microbes. 2026 Apr 13:1-14. doi: 10.1163/18762891-bja00116. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinh Van Hoang, PhD principal investigator
Vietnam National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus casei strain Shirota fermented milk in people with Constipation, run by Yakult Honsha Co., LTD at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05982743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.