ConstipationNCT06014008
Effect of L. Paracasei Strain Shirota on Constipation in Healthy US Adults
A study testing Test product consumption group in people with Constipation, run by Yakult U.S.A. Inc. at 1 site in United States.
Trial summary
The objective of this study is to investigate the efficacy of daily consumption of a fermented milk containing LcS in reducing the frequency of bowel movement with hard or lumpy stools in generally healthy U.S. adult population with intermittent bowel movements producing hard or lumpy stools. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Test product consumption group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to 30 Sep 2024
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ≥18 and <65 years old at Visit 1.
- BMI between ≥18.5 to <30.0 kg/m2.
- Has at least 3 bowel movements per week
- ≥25% of bowel movements during the 2-week screening period produce hard or lumpy stools, defined as a Bristol Stool Form Scale (BSFS) score of 1 or 2 as determined from the participant's self-reported rating.
- Regular breakfast consumer by self-report.
- Has a smartphone supporting either iOS version 11.0 (or later) or Android version 5.0 (or later) operating software capable of downloading and running the Dieta Health app to collect study data.
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- Willing to consume the study product per the protocol instructions throughout the 28-day study intervention period.
- Willing to maintain habitual dietary, lifestyle, and physical activity (with exceptions per study instructions) throughout the trial.
- Willing to refrain from exclusionary medications, supplements, and products throughout the study.
- Willing to limit alcohol consumption to ≤3 standard drinks/day and ≤7 standard drinks/week throughout the trial.
- Non-user of tobacco or nicotine products or former user of any tobacco or nicotine product (not used within 6 months) and has no plans to change during the study period. Tobacco products include tobacco, smoking products (including, but not limited to cigarettes, cigars, chewing tobacco, e-cigarettes), and nicotine products (e.g., nicotine gum and/or nicotine patches) within 6 months of Visit 1 (Day 0) and during the study period.
- Non-user or former user of any marijuana or hemp products (not used within 6 months) of Visit 1 (Day 0) and during the study period and has no plans to use marijuana or hemp products during the study period. No washout is required for topical marijuana or hemp products, but subjects are required to abstain from these products during the study period.
- No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and screening physical exam.
- Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.
Who cannot join
- Any known food allergies or intolerances to dairy or to any of the study product ingredients.
- Consumption of probiotics or fermented products within 14 days of Visit 1 (Day 0) and during the study.
- Presence of a clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), gastric reflux, indigestion, dyspepsia, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food or ingredient allergies). IBS will be determined as recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with: (a) improvement with defecation, (b) onset associated with change in frequency of stool, and (c) onset associated with a change in form (appearance of stool).
- Constipation symptoms caused by primary organic disease of the colon or pelvic floor or, in the Investigator's opinion, caused by medication (e.g., morphine, codeine).
- Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), hepatic, renal (except history of kidney stones in participants who are symptom free for 6 months), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary condition(s). Conditions which are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1 (Day 0). Stable use of hypertension medication is allowed [defined as no change in medication regimen within 90 days of Visit 1 (Day 0)].
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- Weight loss or gain > 4.5 kg within 90 days of Visit 1 (Day 0), or currently or planning to be on a weight loss regimen or muscle-building/strengthening program during the study.
- Signs or symptoms of an active infection of clinical relevance within 5 days of Visit 1 (Day 0). The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to Visit 1 (Day 0).
- Major trauma or any other surgical event within 90 days of Visit 1 (Day 0).
- History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- Use of proton pump inhibitors, H2 receptor antagonists, corticosteroids, antibiotics, antifungals, antiparasitics, antidiarrheals, and/or laxatives within 30 days of Visit 1 (Day 0).
- Regular (>3 days/week) use of NSAIDs within 14 days of Visit 1 (Day 0).
- Exposure to any non-registered drug product within 30 days prior to Visit 1 (Day 0).
- Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception during the study period. The method of contraception must be recorded.
- Recent history (within 12 months of screening; Visit 1; Day 0) of alcohol or substance abuse. Alcohol abuse is defined as >14 drinks/week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Recent (within 2 months) participation in any other clinical study prior to Visit 1 (Day 0).
- Has a condition the Clinical Investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lacticaseibacillus Paracasei Strain Shirota (LcS) in Healthy US Individuals Suffering From Hard or Lumpy Stools: A Randomized Controlled Open Trial.
The objective of this study is to investigate the efficacy of daily consumption of a fermented milk containing LcS in reducing the frequency of bowel movement with hard or lumpy stools in generally healthy U.S. adult population with intermittent bowel movements producing hard or lumpy stools.
- Conditions
- Constipation
- Being tested
- Test product consumption group
- Keywords
- probiotics, Lacticaseibacillus paracasei strain Shirota, Bristol stool form scale, imaging, constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test product consumption groupOther
Participants will take one bottle (80 ml) of Yakult® drink daily for a period of 4 weeks. Yakult is a branded probiotic drink with 8x10^9 CFU Lacticaseibacillus paracasei strain Shirota. Subsequently, a two-week follow-up period will follow.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention group | No intervention | Not taking test product |
| Test product consumption group | Experimental | Participants will take one bottle (80 ml) of Yakult® drink daily for a period of 4 weeks. Yakult is a branded probiotic drink with 8x10^9 CFU Lacticaseibacillus paracasei strain Shirota. Subsequently, a two-week follow-up period will follow. Receives: Other: Test product consumption group |
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 (Subjectively evaluated Bristol stool form scale (BSFS) score of 1 or 2, ) ≥ 25% of bowel movements.
Compare the odds ratio of active to control of subjects with hard or lumpy stools (BSFS score of 1 or 2 as determined from the participant's self-reported rating) in at least 25% of the weekly bowel movements.
Measured: Four-week period from the start to the end of test product consumption.
Secondary outcomes (11)
Proportion of subjects that produce hard or lumpy stools (Objectively evaluated Bristol stool form scale (BSFS) score of 1 or 2, ) ≥ 25% of bowel movements.
Compare the odds ratio of active to control of subjects with hard or lumpy stools (BSFS score of 1 or 2 as determined by Dieta Health application stool image analysis) in at least 25% of the weekly bowel movements.
Measured: Four-week period from the start to the end of test product consumption.
Odds ratio of active to control of subjects who had improved hard or lumpy stool ratio from baseline (BSFS score 1 or 2 as determined by Dieta Health application stool image analysis.
Measured: Four-week period from the start to the end of test product consumption.
Odds ratio of active to control of subjects who had improved hard or lumpy stool ratio from baseline (BSFS score 1 or 2 as determined from the participant's self-reported rating.
Measured: Four-week period from the start to the end of test product consumption.
Difference between groups in the stool consistency as collected by Dieta Health application stool image analysis.
Measured: Four-week period from the start to the end of test product consumption.
Difference between groups in the stool fuzziness as collected by Dieta Health application stool image analysis.
Measured: Four-week period from the start to the end of test product consumption.
Difference between groups in the stool fragmentation as collected by Dieta Health application stool image analysis.
Measured: Four-week period from the start to the end of test product consumption.
Difference between groups in the stool volume as collected by Dieta Health application stool image analysis.
Measured: Four-week period from the start to the end of test product consumption.
Difference between groups in the stool frequency as collected by Dieta Health application stool image analysis.
Measured: Four-week period from the start to the end of test product consumption.
Difference between groups in total and sub scores of PAC-QOL questionnaire.
Measured: Four-week period from the start to the end of test product consumption.
Difference between groups in the proportion of bowel movements having straining during evacuation.
Measured: Four-week period from the start to the end of test product consumption.
Difference between groups in the proportion of bowel movement having sensation of remaining stool in the rectum after evacuation.
Measured: Four-week period from the start to the end of test product consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start18 Sep 2023
- Primary completion13 May 2024
- Study completion30 Sep 2024
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yakult U.S.A. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis, Dieta Inc.
- Responsible party
- Sponsor
- Investigators
- Aditi Shah, MD, Principal investigator, BioFortis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014008
- Sponsor's protocol ID
- BIO-2310
- Status last verified
- Oct 2024
- First submitted
- 22 Aug 2023
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cook CM, Akiyama T, Blonquist T, Mah E, Derrig L, Shibata H. Effect of Daily Consumption of a Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota (LcS) on Stool Consistency in United States Adults with Hard or Lumpy Stools: A Randomized Controlled Trial. J Nutr. 2025 Apr;155(4):1183-1192. doi: 10.1016/j.tjnut.2025.02.021. Epub 2025 Feb 28.
PubMed 40024315
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lacticaseibacillus Paracasei Strain Shirota (LcS) in Healthy US Individuals Suffering From Hard or Lumpy Stools: A Randomized Controlled Open Trial.
- ClinicalTrials.gov ID
- NCT06014008
- Acronym / sponsor ID
- BIO-2310
- Conditions
- Constipation
- Keywords
- probiotics, Lacticaseibacillus paracasei strain Shirota, Bristol stool form scale, imaging, constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yakult U.S.A. Inc.Industry (pharma, biotech, devices)
- Collaborators
- BioFortis, Dieta Inc.
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 28 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 investigate the efficacy of daily consumption of a fermented milk containing LcS in reducing the frequency of bowel movement with hard or lumpy stools in generally healthy U.S. adult population with intermittent bowel movements producing hard or lumpy stools.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention group | No intervention | –Not taking test product |
| Test product consumption group | Experimental | Other: Test product consumption groupParticipants will take one bottle (80 ml) of Yakult® drink daily for a period of 4 weeks. Yakult is a branded probiotic drink with 8x10^9 CFU Lacticaseibacillus paracasei strain Shirota. Subsequently, a two-week follow-up period will follow. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- ≥18 and <65 years old at Visit 1.
- BMI between ≥18.5 to <30.0 kg/m2.
- Has at least 3 bowel movements per week
- ≥25% of bowel movements during the 2-week screening period produce hard or lumpy stools, defined as a Bristol Stool Form Scale (BSFS) score of 1 or 2 as determined from the participant's self-reported rating.
- Regular breakfast consumer by self-report.
Key exclusion criteria (17 listed)
- Any known food allergies or intolerances to dairy or to any of the study product ingredients.
- Consumption of probiotics or fermented products within 14 days of Visit 1 (Day 0) and during the study.
- Presence of a clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), gastric reflux, indigestion, dyspepsia, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food or ingredient allergies). IBS will be determined as recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with: (a) improvement with defecation, (b) onset associated with change in frequency of stool, and (c) onset associated with a change in form (appearance of stool).
- Constipation symptoms caused by primary organic disease of the colon or pelvic floor or, in the Investigator's opinion, caused by medication (e.g., morphine, codeine).
- Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), hepatic, renal (except history of kidney stones in participants who are symptom free for 6 months), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary condition(s). Conditions which are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
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 |
|---|---|---|
| Test product consumption groupParticipants will take one bottle (80 ml) of Yakult® drink daily for a period of 4 weeks. Yakult is a branded probiotic drink with 8x10^9 CFU Lacticaseibacillus paracasei strain Shirota. Subsequently, a two-week follow-up period will follow. | Other | Test product consumption group |
Primary outcome
Proportion of subjects that produce hard or lumpy stools (Subjectively evaluated Bristol stool form scale (BSFS) score of 1 or 2, ) ≥ 25% of bowel movements.
Time frame: Four-week period from the start to the end of test product consumption.
Compare the odds ratio of active to control of subjects with hard or lumpy stools (BSFS score of 1 or 2 as determined from the participant's self-reported rating) in at least 25% of the weekly bowel movements.
11 secondary outcomes
Proportion of subjects that produce hard or lumpy stools (Objectively evaluated Bristol stool form scale (BSFS) score of 1 or 2, ) ≥ 25% of bowel movements.
Time frame: Four-week period from the start to the end of test product consumption.
Odds ratio of active to control of subjects who had improved hard or lumpy stool ratio from baseline (BSFS score 1 or 2 as determined by Dieta Health application stool image analysis.
Time frame: Four-week period from the start to the end of test product consumption.
Odds ratio of active to control of subjects who had improved hard or lumpy stool ratio from baseline (BSFS score 1 or 2 as determined from the participant's self-reported rating.
Time frame: Four-week period from the start to the end of test product consumption.
Difference between groups in the stool consistency as collected by Dieta Health application stool image analysis.
Time frame: Four-week period from the start to the end of test product consumption.
Difference between groups in the stool fuzziness as collected by Dieta Health application stool image analysis.
Time frame: Four-week period from the start to the end of test product consumption.
Difference between groups in the stool fragmentation as collected by Dieta Health application stool image analysis.
Time frame: Four-week period from the start to the end of test product consumption.
Difference between groups in the stool volume as collected by Dieta Health application stool image analysis.
Time frame: Four-week period from the start to the end of test product consumption.
Difference between groups in the stool frequency as collected by Dieta Health application stool image analysis.
Time frame: Four-week period from the start to the end of test product consumption.
Difference between groups in total and sub scores of PAC-QOL questionnaire.
Time frame: Four-week period from the start to the end of test product consumption.
Difference between groups in the proportion of bowel movements having straining during evacuation.
Time frame: Four-week period from the start to the end of test product consumption.
Difference between groups in the proportion of bowel movement having sensation of remaining stool in the rectum after evacuation.
Time frame: Four-week period from the start to the end of test product consumption.
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 22 Oct 2024.
- Derived from this study: PubMed 40024315Cook CM, Akiyama T, Blonquist T, Mah E, Derrig L, Shibata H. Effect of Daily Consumption of a Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota (LcS) on Stool Consistency in United States Adults with Hard or Lumpy Stools: A Randomized Controlled Trial. J Nutr. 2025 Apr;155(4):1183-1192. doi: 10.1016/j.tjnut.2025.02.021. Epub 2025 Feb 28.
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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.
Aditi Shah, MD principal investigator
BioFortis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test product consumption group in people with Constipation, run by Yakult U.S.A. Inc. at 1 site in United States.
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 14 inclusion and 17 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 22 Oct 2024. 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 United States. 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 (Subjectively evaluated Bristol stool form scale (BSFS) score of 1 or 2, ) ≥ 25% of bowel movements. (time frame: Four-week period from the start to the end of test product consumption.). 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 NCT06014008, 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 22 Oct 2024.