ConstipationNCT07462481
Probiotic Improve Constipation
A study testing Probiotic and High-activity probiotic probiotic in people with Constipation, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy and safety of probiotic as a food supplement in regulating bowel habits in patients with chronic constipation, and to compare it with placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Probiotic and High-activity probiotic probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2026to 1 Aug 2027
- 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
- Age 18-65 years; (2) Constipated patients (less than 3 bowel movements per week and/or Bristol Scale type 1 and 2); (3) Able to complete the study according to the trial protocol; (4) Patients who have signed the informed consent form; (5) Study participants (including male study participants) have no plans to have children within 14 days prior to screening and within 6 months after the end of the trial and voluntarily use effective contraception.
- -
Who cannot join
- Those who have taken a substance with a similar function to the test subject in a short period of time, affecting their judgment of the results;
- Patients who changed their diet during the study;
- Patients with severe allergies and immunodeficiency;
- Pregnant, breastfeeding, or women planning to become pregnant;
- Those with severe diseases of vital organs such as the cardiovascular system, lungs, liver, and kidneys, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, or severe immune system diseases;
- Those who have used antibiotics in the past two weeks;
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- Those with severe psychological or mental illnesses;
- Those who did not consume the test sample as required or did not follow up on time, resulting in the inability to determine the efficacy;
- Other study participants deemed unsuitable by the researchers. -
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, Jiangsu, 215000
Ying Jin, Doctor, 18336086291, 1959643812@qq.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Probiotics in Relieving Constipation in Adults
To evaluate the efficacy and safety of probiotic as a food supplement in regulating bowel habits in patients with chronic constipation, and to compare it with placebo.
- Conditions
- Constipation
- Being tested
- Probiotic, Placebo, High-activity probiotic probiotic
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8.
PlaceboDietary supplement
The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8.
High-activity probiotic probioticDietary supplement
The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group | Experimental | Taking 60 billion CFU of Lactobacillus plantarum Lp18 daily; Storage: Store in a cool, dry palce without sun expouse. Receives: Dietary Supplement: Probiotic |
| Placebo Group | Placebo comparator | Take 3g of maltodextrin daily; the product packaging is the same as that of probiotic products. Receives: Dietary Supplement: Placebo |
| High-activity probiotic group | Experimental | Taking 300 billion CFU of Lactobacillus plantarum Lp18 daily; Storage: Store in a cool, dry palce without sun expouse. Receives: Dietary Supplement: High-activity probiotic probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of constipation symptoms
Improvement in constipation was assessed using the Bristol Stool Characteristics Scale (BSFS), primarily observing the shift in stool type from type 1-2 (hard stool/constipation) to type 3-4 (normal/ideal soft stool).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start10 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Aug 2027 (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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 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
- NCT07462481
- Sponsor's protocol ID
- WK20260305
- Status last verified
- Jun 2026
- First submitted
- 4 Mar 2026
- Last updated
- 9 Jun 2026
- 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 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Probiotics in Relieving Constipation in Adults
- ClinicalTrials.gov ID
- NCT07462481
- Acronym / sponsor ID
- WK20260305
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 10 Mar 2026 (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.
To evaluate the efficacy and safety of probiotic as a food supplement in regulating bowel habits in patients with chronic constipation, and to compare it with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Experimental | Dietary Supplement: ProbioticTaking 60 billion CFU of Lactobacillus plantarum Lp18 daily; Storage: Store in a cool, dry palce without sun expouse. |
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboTake 3g of maltodextrin daily; the product packaging is the same as that of probiotic products. |
| High-activity probiotic group | Experimental | Dietary Supplement: High-activity probiotic probioticTaking 300 billion CFU of Lactobacillus plantarum Lp18 daily; Storage: Store in a cool, dry palce without sun expouse. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-65 years; (2) Constipated patients (less than 3 bowel movements per week and/or Bristol Scale type 1 and 2); (3) Able to complete the study according to the trial protocol; (4) Patients who have signed the informed consent form; (5) Study participants (including male study participants) have no plans to have children within 14 days prior to screening and within 6 months after the end of the trial and voluntarily use effective contraception.
- -
Key exclusion criteria (9 listed)
- Those who have taken a substance with a similar function to the test subject in a short period of time, affecting their judgment of the results;
- Patients who changed their diet during the study;
- Patients with severe allergies and immunodeficiency;
- Pregnant, breastfeeding, or women planning to become pregnant;
- Those with severe diseases of vital organs such as the cardiovascular system, lungs, liver, and kidneys, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, or severe immune system diseases;
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 |
|---|---|---|
| ProbioticThe intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8. | Dietary supplement | Probiotic Group |
| PlaceboThe intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8. | Dietary supplement | Placebo Group |
| High-activity probiotic probioticThe intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8. | Dietary supplement | High-activity probiotic group |
Primary outcome
Improvement of constipation symptoms
Time frame: 8 weeks
Improvement in constipation was assessed using the Bristol Stool Characteristics Scale (BSFS), primarily observing the shift in stool type from type 1-2 (hard stool/constipation) to type 3-4 (normal/ideal soft stool).
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 9 Jun 2026.
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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 and High-activity probiotic probiotic in people with 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 2 inclusion and 9 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 9 Jun 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 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 (18336086291, 1959643812@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of constipation symptoms (time frame: 8 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 9 Jun 2026.