ConstipationNCT07083596
Efficacy of LcS-Fermented Milk on Constipation-Related Symptoms in Filipino Adults
A study testing Experimental: Probiotic with LcS in people with Constipation and Gastrointestinal Discomfort, run by University of Santo Tomas at 1 site in Philippines.
Trial summary
The primary purpose of this study is to investigate whether the consumption of a probiotic drink (with Lacticaseibacillus paracasei strain Shirota (LcS)) relieves constipation-related symptoms of Filipino adults, specifically its effect on stool consistency, frequency, and duration, and on gastrointestinal discomfort. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation, Gastrointestinal Discomfort
- What is being tested?
- Experimental: Probiotic with LcS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePhilippines
- Study dates
- 22 Apr 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Filipino adult male or female aged 18 to 59 years old
- Apparently healthy adults with constipation-related symptoms of hard to lumpy stools (Bristol Stool Form Scale 1-2) in 25% or more of defecations in a week
- With cold storage at home
Who cannot join
- Habitual intake of food items containing probiotics and prebiotics as food supplements (previous 3 months, at least three times per week)
- Constipation due to organic or neurologic origin
- High fiber intake (>30 g/day)
- Pregnant or lactating
- Allergy to dairy products and/or lactose intolerance
- Use of laxatives, anticholinergics and medications for constipation or diarrhea within the past three months
Show all 12Show fewer
- Use of antibiotics within the past two weeks
- Presence of chronic diseases such as diabetes mellitus and its complications, cardiovascular diseases, kidney problems
- GI condition that may interfere with the evaluation of the outcome such as hemorrhoids, intestinal obstruction and inflammatory bowel diseases
- Recent history of any gastrointestinal surgery
- Have pre-existing medical conditions like hypo- or hyperthyroidism and congenital abnormalities
- Participation in another study with test product two months prior the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Philippines1 site, 1 recruiting
- Recruiting
University of Santo Tomas
Manila, Manila, 1015
Diane S Mendoza-Sarmiento, Ph.D in Health Research, +639088738336, dsmendoza@ust.edu.ph
Nicole Sison, MS in Food Science, ndsison@ust.edu.ph
About this study
Official title: The Efficacy of Fermented Milk Drink With Lacticaseibacillus Paracasei Strain Shirota (LcS) on Relieving Constipation-Related Symptoms of Filipino Adults
The primary purpose of this study is to investigate whether the consumption of a probiotic drink (with Lacticaseibacillus paracasei strain Shirota (LcS)) relieves constipation-related symptoms of Filipino adults, specifically its effect on stool consistency, frequency, and duration, and on gastrointestinal discomfort.
Read the detailed description
The goal of this clinical trial is to test if probiotic drink with LcS consumption can improve constipation-related symptoms. The main question[s] it aims to answer are:
- Will a probiotic drink with LcS improve stool consistency after four weeks?
- Will a probiotic drink with LcS improve stool frequency and duration after four weeks?
- Will a probiotic drink with LcS improve gastrointestinal discomfort after four weeks?
Participants will consume probiotic drink with LcS once a day for four weeks while maintaining their usual physical activity. Researchers will compare the control group and the probiotic group to see if there are differences in stool consistency, frequency and duration, and gastrointestinal symptoms.
- Conditions
- Constipation, Gastrointestinal Discomfort
- Being tested
- Experimental: Probiotic with LcS, Control
- Keywords
- probiotic, Lacticaseibacillus paracasei strain Shirota, constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Probiotic with LcSOther
Probiotic drink with LcS will be consumed once per day for four weeks
ControlOther
Brochure containing recommendations to improve constipation will be provided at start of study.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Probiotic drink with Lacticaseibacillus paracasei strain Shirota will be consumed once per day for four weeks. Brochure containing recommendations to improve constipation will be provided at the start of study. Receives: Other: Experimental: Probiotic with LcS |
| Control | Placebo comparator | Brochure containing recommendations to improve constipation will be provided at the start of study. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stool consistency
Bristol Stool Consistency Score:
Type 1: Separate hard lumps, like nuts (hard to pass); Severe Constipation. Type 2: Sausage-shaped, but lumpy; Mild Constipation. Type 3: Like a sausage, but with cracks on its surface; Normal. Type 4: Like a sausage or snake, smooth and soft; Normal. Type 5: Soft blobs with clear-cut edges (passed easily); Borderline Normal. Type 6: Fluffy pieces with ragged edges, a mushy stool; Mild diarrhea. Type 7: Watery, no solid pieces, entirely liquid; Severe diarrhea.
Measured: Four weeks
Secondary outcomes (3)
Change in the Frequency of Bowel Movement
Frequency of Bowel Movement- recorded as the number of bowel movements per day and reported as the daily average bowel movement in a week
Measured: four weeks
Change in the Duration of Bowel Movement
Duration of Bowel movement will be recorded in minutes in the lavatory per bowel movement per day and reported as the daily average minutes in a week.
Measured: Four weeks
Change in the Gastrointestinal Well-being (Patient Assessment of Constipation Symptoms)
This includes measures of abdominal discomfort and pain, painful bowel movement, bloating, a sense of incomplete bowel movement, straining during bowel movement, and unsuccessful bowel movement using a five-point scale (PAC-SYM).
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start22 Apr 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santo Tomas
- Sponsor type
- University, hospital or other
- Collaborators
- Yakult Honsha Co., LTD
- Responsible party
- Principal investigator, Diane S. Mendoza-Sarmiento, University of Santo Tomas
- Investigators
- Diane S MENDOZA-SARMIENTO, Ph.D in Health Research, Principal investigator, University of Santo TomasLeslie Michelle M Dalmacio, Ph.D in Molecular Biology, Study chair, University of the Philippines-Manila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083596
- Sponsor's protocol ID
- REC-2025-06-084-CT-AP
- Other IDs
- 2025-06-084-CT-R1
- Status last verified
- Apr 2026
- First submitted
- 6 Jul 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Fermented Milk Drink With Lacticaseibacillus Paracasei Strain Shirota (LcS) on Relieving Constipation-Related Symptoms of Filipino Adults
- ClinicalTrials.gov ID
- NCT07083596
- Acronym / sponsor ID
- REC-2025-06-084-CT-AP
- Conditions
- Constipation, Gastrointestinal Discomfort
- Keywords
- probiotic, Lacticaseibacillus paracasei strain Shirota, constipation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Santo TomasUniversity, hospital or other
- Collaborators
- Yakult Honsha Co., LTD
- Study start
- 22 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 24 Jul 2025 (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 primary purpose of this study is to investigate whether the consumption of a probiotic drink (with Lacticaseibacillus paracasei strain Shirota (LcS)) relieves constipation-related symptoms of Filipino adults, specifically its effect on stool consistency, frequency, and duration, and on gastrointestinal discomfort.
Detailed description
The goal of this clinical trial is to test if probiotic drink with LcS consumption can improve constipation-related symptoms. The main question[s] it aims to answer are:
- Will a probiotic drink with LcS improve stool consistency after four weeks?
- Will a probiotic drink with LcS improve stool frequency and duration after four weeks?
- Will a probiotic drink with LcS improve gastrointestinal discomfort after four weeks?
Participants will consume probiotic drink with LcS once a day for four weeks while maintaining their usual physical activity. Researchers will compare the control group and the probiotic group to see if there are differences in stool consistency, frequency and duration, and gastrointestinal symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Other: Experimental: Probiotic with LcSProbiotic drink with Lacticaseibacillus paracasei strain Shirota will be consumed once per day for four weeks. Brochure containing recommendations to improve constipation will be provided at the start of study. |
| Control | Placebo comparator | Other: ControlBrochure containing recommendations to improve constipation will be provided at the start of study. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Filipino adult male or female aged 18 to 59 years old
- Apparently healthy adults with constipation-related symptoms of hard to lumpy stools (Bristol Stool Form Scale 1-2) in 25% or more of defecations in a week
- With cold storage at home
Key exclusion criteria (12 listed)
- Habitual intake of food items containing probiotics and prebiotics as food supplements (previous 3 months, at least three times per week)
- Constipation due to organic or neurologic origin
- High fiber intake (>30 g/day)
- Pregnant or lactating
- Allergy to dairy products and/or lactose intolerance
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 |
|---|---|---|
| Experimental: Probiotic with LcSProbiotic drink with LcS will be consumed once per day for four weeks | Other | Probiotic |
| ControlBrochure containing recommendations to improve constipation will be provided at start of study. | Other | Control |
Primary outcome
Change in stool consistency
Time frame: Four weeks
Bristol Stool Consistency Score: Type 1: Separate hard lumps, like nuts (hard to pass); Severe Constipation. Type 2: Sausage-shaped, but lumpy; Mild Constipation. Type 3: Like a sausage, but with cracks on its surface; Normal. Type 4: Like a sausage or snake, smooth and soft; Normal. Type 5: Soft blobs with clear-cut edges (passed easily); Borderline Normal. Type 6: Fluffy pieces with ragged edges, a mushy stool; Mild diarrhea. Type 7: Watery, no solid pieces, entirely liquid; Severe diarrhea.
3 secondary outcomes
Change in the Frequency of Bowel Movement
Time frame: four weeks
Change in the Duration of Bowel Movement
Time frame: Four weeks
Change in the Gastrointestinal Well-being (Patient Assessment of Constipation Symptoms)
Time frame: four weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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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.
Diane S MENDOZA-SARMIENTO, Ph.D in Health Research principal investigator
University of Santo Tomas
Leslie Michelle M Dalmacio, Ph.D in Molecular Biology study chair
University of the Philippines-Manila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Probiotic with LcS in people with Constipation and Gastrointestinal Discomfort, run by University of Santo Tomas at 1 site in Philippines.
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 3 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 4 May 2026. 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 Philippines. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diane S Mendoza-Sarmiento, Ph.D (+639088738336, dsmendoza@ust.edu.ph), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stool consistency (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.