Chronic ConstipationNCT06847919
Exploring the Potential Benefits of Probiotic Yogurt
A study testing Probiotic yogurt group in people with Chronic Constipation, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
This study aims to evaluate the effect of a high-activity probiotic yogurt on improving symptoms of chronic constipation, observing its regulatory effects on the gut microbiota and the incidence of adverse reactions in study participants over a 21-day intervention period. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- Probiotic yogurt group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2025to 30 Dec 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meet the Rome IV diagnosis criteria for chronic constipation;
- Patients who are able to understand clinical studies and are committed to complying with study requirements and procedures;
- Age 18-65. -
Who cannot join
- Systemic (diabetes, autoimmune diseases, cancer), gastrointestinal or liver diseases known to be associated with alterations in the gut microbiota;
- Patients who are pregnant or lactating;
- have taken antimicrobials, probiotics, or drugs that inhibit stomach acid or gastrointestinal motility in the past 6 weeks;
- Patients who changed their diet type during the study;
- Patients who are allergic or intolerant to any component of the investigational product formulation;
- Patients with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious diseases and endocrine diseases, mental patients;
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- Stop taking the tested sample or add other drugs in the middle, unable to judge the efficacy or incomplete data;
- short-term use of objects related to the function of the test, affecting the judgment of the result;
- have been dieting, exercising excessively, taking weight loss medications or taking medications that may affect appetite in the past 3 months;
- Current or past excessive use of alcohol, drugs, or supplements that may cause intestinal dysfunction or interfere with the evaluation of the efficacy of the study product -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Suzhou Ninth People's Hospital Suzhou Ninth Hospital affiliated to Soochow University
Suzhou, Jiangsu, 215200
Ying Jin, Doctor, sunny13211@sina.com
About this study
Official title: Exploring the Potential Benefits of High-activity Probiotic Yogurt: a Randomized, Double-blind, Placebo-controlled Trial
This study aims to evaluate the effect of a high-activity probiotic yogurt on improving symptoms of chronic constipation, observing its regulatory effects on the gut microbiota and the incidence of adverse reactions in study participants over a 21-day intervention period.
- Conditions
- Chronic Constipation
- Being tested
- Probiotic yogurt group, Yogurt control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic yogurt groupDietary supplement
The intervention phase of this study will last 3 weeks, and each participant will make 3 visits (week 0, week 1, week 3).
Yogurt control groupDietary supplement
The intervention phase of this study will last 3 weeks, and each participant will make 3 visits (week 0, week 1, week 3).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Active comparator | Bacterial count: ≥1000 billion CFUs per bottle Take one bottle of yogurt per day for 3 weeks Receives: Dietary Supplement: Probiotic yogurt group |
| Placebo group | Placebo comparator | Product name: placebo yogurt Take one bottle of yogurt per day for 3 weeks Receives: Dietary Supplement: Yogurt control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation symptom improvement
The Bristol Stool Form Scale (BSFS) will be used to assess improvements in constipation. The BSFS is a 9-point scale ranging from 1 to 7, where higher scores indicate softer stool consistency, approaching a liquid state. The specific scoring is as follows:
- Separate hard lumps, like nuts (difficult to pass)
- Sausage-shaped but lumpy
- Like a sausage but with cracks on the surface
- Like a sausage or snake, smooth and soft
- Soft blobs with clear-cut edges (passed easily)
- Fluffy pieces with ragged edges, a mushy stool
- Watery, no solid pieces, entirely liquid Scores of 4, 5, and 6 are generally considered ideal, indicating smooth bowel movements without constipation.
Therefore, higher scores (closer to 4-6) represent improved constipation symptoms, while lower scores (1-3) indicate more severe constipation.
Measured: 3 weeks
Secondary outcomes (4)
Gut microbiota composition and diversity
Evaluating the changes in the composition and diversity of the gut microbiota before and after the intake of probiotic yogurt using high-throughput sequencing technology.
Measured: 3 weeks
Emotional state changes
Hospital Anxiety and Depression Scale (HADS) The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in participants' emotional state during the study period. The HADS consists of two subscales: one for anxiety (HADS-A) and one for depression (HADS-D), each containing 7 items.
Scoring Range: Each subscale is scored from 0 to 21. Interpretation: Higher scores indicate greater levels of anxiety or depression.
Measured: 3 weeks
Emotional state changes
Depression Anxiety Stress Scales (DASS) The Depression Anxiety Stress Scales (DASS) will be used to assess changes in participants' emotional state during the study period. The DASS includes three subscales: Depression (DASS-D), Anxiety (DASS-A), and Stress (DASS-S), each containing 14 items.
Scoring Range: Each subscale is scored from 0 to 42. Interpretation: Higher scores indicate greater levels of depression, anxiety, or stress.
Measured: 3 weeks
Weight management impact
Assessing the impact of probiotic yogurt intake on participants' weight management by measuring body weight.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start25 Feb 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConstipationStudies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847919
- Sponsor's protocol ID
- WK20250207
- Status last verified
- Mar 2025
- First submitted
- 8 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Potential Benefits of High-activity Probiotic Yogurt: a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06847919
- Acronym / sponsor ID
- WK20250207
- Conditions
- Chronic Constipation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 26 Feb 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.
This study aims to evaluate the effect of a high-activity probiotic yogurt on improving symptoms of chronic constipation, observing its regulatory effects on the gut microbiota and the incidence of adverse reactions in study participants over a 21-day intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Active comparator | Dietary Supplement: Probiotic yogurt groupBacterial count: ≥1000 billion CFUs per bottle Take one bottle of yogurt per day for 3 weeks |
| Placebo group | Placebo comparator | Dietary Supplement: Yogurt control groupProduct name: placebo yogurt Take one bottle of yogurt per day for 3 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meet the Rome IV diagnosis criteria for chronic constipation;
- Patients who are able to understand clinical studies and are committed to complying with study requirements and procedures;
- Age 18-65. -
Key exclusion criteria (10 listed)
- Systemic (diabetes, autoimmune diseases, cancer), gastrointestinal or liver diseases known to be associated with alterations in the gut microbiota;
- Patients who are pregnant or lactating;
- have taken antimicrobials, probiotics, or drugs that inhibit stomach acid or gastrointestinal motility in the past 6 weeks;
- Patients who changed their diet type during the study;
- Patients who are allergic or intolerant to any component of the investigational product formulation;
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 |
|---|---|---|
| Probiotic yogurt groupThe intervention phase of this study will last 3 weeks, and each participant will make 3 visits (week 0, week 1, week 3). | Dietary supplement | Probiotic group |
| Yogurt control groupThe intervention phase of this study will last 3 weeks, and each participant will make 3 visits (week 0, week 1, week 3). | Dietary supplement | Placebo group |
Primary outcome
Constipation symptom improvement
Time frame: 3 weeks
The Bristol Stool Form Scale (BSFS) will be used to assess improvements in constipation. The BSFS is a 9-point scale ranging from 1 to 7, where higher scores indicate softer stool consistency, approaching a liquid state. The specific scoring is as follows: 1. Separate hard lumps, like nuts (difficult to pass) 2. Sausage-shaped but lumpy 3. Like a sausage but with cracks on the surface 4. Like a sausage or snake, smooth and soft 5. Soft blobs with clear-cut edges (passed easily) 6. Fluffy pieces with ragged edges, a mushy stool 7. Watery, no solid pieces, entirely liquid Scores of 4, 5, and 6 are generally considered ideal, indicating smooth bowel movements without constipation. Therefore, higher scores (closer to 4-6) represent improved constipation symptoms, while lower scores (1-3) indicate more severe constipation.
4 secondary outcomes
Gut microbiota composition and diversity
Time frame: 3 weeks
Emotional state changes
Time frame: 3 weeks
Emotional state changes
Time frame: 3 weeks
Weight management impact
Time frame: 3 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 5 Mar 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic yogurt group in people with Chronic Constipation, run by Wecare Probiotics Co., Ltd. at 1 site in China.
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 10 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 5 Mar 2025. 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 China. 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 Ying Jin, Doctor (13375163966, sunny13211@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation symptom improvement (time frame: 3 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 5 Mar 2025.