Functional ConstipationNCT07507955
Probiotics for Constipation Relief in Adults
A study testing Probiotic, Maltodextrin and High-activity probiotic group in people with Functional Constipation, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of Bifidobacterium animalis subsp. lactis BLa36 in adults with functional constipation. In this randomized, double-blind, placebo-controlled trial, participants will receive BLa36 supplementation or placebo for 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation
- What is being tested?
- Probiotic, Maltodextrin and High-activity probiotic group
- Type of treatment
- Pill or oral medicine
- 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 20 Jan 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
- Adults aged 18-65 years;
- Individuals diagnosed with constipation, defined as fewer than 3 bowel movements per week and/or Bristol Stool Form Scale (BSFS) types 1-2;
- Able and willing to comply with all study procedures and complete the study;
- Provided written informed consent prior to participation;
- Participants (including males) must have no intention of conception from 14 days before screening until 6 months after study completion and agree to use effective contraception.
Who cannot join
- Recent use of products with similar effects that may interfere with study outcomes; Significant dietary changes during the study period;
- History of severe allergy or immunodeficiency;
- Pregnant or breastfeeding women, or those planning pregnancy;
- Presence of serious systemic diseases (e.g., cardiovascular, pulmonary, hepatic, renal, endocrine, or malignant conditions);
- Use of antibiotics within the past 2 weeks;
- Individuals with severe psychiatric or neurological disorders;
- Poor compliance, including failure to take the study product or attend scheduled visits;
- Any other condition deemed unsuitable by the investigator.
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
Suzhou Ninth People's Hospital
Suzhou, Jiangsu, 215000
Ying Jin, Doctor, 18336086291, 1959643812@qq.com
About this study
Official title: To Evaluate the Efficacy and Safety of Probiotics in Alleviating Constipation in Adults Through a Randomized, Double-blind, Placebo-controlled Trial
This study aims to evaluate the efficacy and safety of Bifidobacterium animalis subsp. lactis BLa36 in adults with functional constipation. In this randomized, double-blind, placebo-controlled trial, participants will receive BLa36 supplementation or placebo for 8 weeks. Clinical outcomes will be assessed using validated gastrointestinal symptom scales, stool characteristics, and quality-of-life measures. In addition, changes in inflammatory and immune markers, gut microbiota composition, metabolic indicators, and gut-brain axis-related parameters will be evaluated to comprehensively determine the effects of BLa36 on intestinal function and overall health.
- Conditions
- Functional Constipation
- Being tested
- Probiotic, Maltodextrin, High-activity probiotic group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
BLa36 will be administered orally once daily for 8 weeks. Follow-up assessments will be conducted at Week 0, Week 4, and Week 8.
MaltodextrinDietary supplement
Maltodextrin will be administered orally once daily for 8 weeks. Follow-up assessments will be conducted at Week 0, Week 4, and Week 8.
High-activity probiotic groupDietary supplement
BLa36 will be administered orally once daily for 8 weeks. Follow-up assessments will be conducted at Week 0, Week 4, and Week 8.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Participants in this group will receive Bifidobacterium animalis subsp. lactis BLa36 at a dose of 3 g per sachet, administered once daily for 8 weeks. Receives: Dietary Supplement: Probiotic |
| Placebo group | Placebo comparator | Participants in this group will receive a placebo containing maltodextrin (3 g per sachet), administered once daily for 8 weeks, matched in appearance and administration to the active product. Receives: Dietary Supplement: Maltodextrin |
| High-activity probiotic group | Experimental | Participants in this group will receive Bifidobacterium animalis subsp. lactis BLa36 at a dose of 3 g per sachet, administered once daily for 8 weeks. Receives: Dietary Supplement: High-activity probiotic group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of constipation symptoms
Improvement in constipation will be evaluated using the Bristol Stool Form Scale (BSFS), with particular focus on changes in stool form from type 1-2 (hard stools/constipation) toward type 3-4 (normal stool consistency).
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 posted2 Apr 2026
- Study start10 Jun 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional 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
- Participant
- 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
- NCT07507955
- Sponsor's protocol ID
- WK20260328
- Status last verified
- Jun 2026
- First submitted
- 27 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
- To Evaluate the Efficacy and Safety of Probiotics in Alleviating Constipation in Adults Through a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07507955
- Acronym / sponsor ID
- WK20260328
- Conditions
- Functional Constipation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 2 Apr 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.
This study aims to evaluate the efficacy and safety of Bifidobacterium animalis subsp. lactis BLa36 in adults with functional constipation. In this randomized, double-blind, placebo-controlled trial, participants will receive BLa36 supplementation or placebo for 8 weeks. Clinical outcomes will be assessed using validated gastrointestinal symptom scales, stool characteristics, and quality-of-life measures. In addition, changes in inflammatory and immune markers, gut microbiota composition, metabolic indicators, and gut-brain axis-related parameters will be evaluated to comprehensively determine the effects of BLa36 on intestinal function and overall health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: ProbioticParticipants in this group will receive Bifidobacterium animalis subsp. lactis BLa36 at a dose of 3 g per sachet, administered once daily for 8 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: MaltodextrinParticipants in this group will receive a placebo containing maltodextrin (3 g per sachet), administered once daily for 8 weeks, matched in appearance and administration to the active product. |
| High-activity probiotic group | Experimental | Dietary Supplement: High-activity probiotic groupParticipants in this group will receive Bifidobacterium animalis subsp. lactis BLa36 at a dose of 3 g per sachet, administered once daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-65 years;
- Individuals diagnosed with constipation, defined as fewer than 3 bowel movements per week and/or Bristol Stool Form Scale (BSFS) types 1-2;
- Able and willing to comply with all study procedures and complete the study;
- Provided written informed consent prior to participation;
- Participants (including males) must have no intention of conception from 14 days before screening until 6 months after study completion and agree to use effective contraception.
Key exclusion criteria (8 listed)
- Recent use of products with similar effects that may interfere with study outcomes; Significant dietary changes during the study period;
- History of severe allergy or immunodeficiency;
- Pregnant or breastfeeding women, or those planning pregnancy;
- Presence of serious systemic diseases (e.g., cardiovascular, pulmonary, hepatic, renal, endocrine, or malignant conditions);
- Use of antibiotics within the past 2 weeks;
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 |
|---|---|---|
| ProbioticBLa36 will be administered orally once daily for 8 weeks. Follow-up assessments will be conducted at Week 0, Week 4, and Week 8. | Dietary supplement | Probiotic group |
| MaltodextrinMaltodextrin will be administered orally once daily for 8 weeks. Follow-up assessments will be conducted at Week 0, Week 4, and Week 8. | Dietary supplement | Placebo group |
| High-activity probiotic groupBLa36 will be administered orally once daily for 8 weeks. Follow-up assessments will be conducted at 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 will be evaluated using the Bristol Stool Form Scale (BSFS), with particular focus on changes in stool form from type 1-2 (hard stools/constipation) toward type 3-4 (normal stool consistency).
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, Maltodextrin and High-activity probiotic group in people with Functional 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 5 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: opening soon, 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.