ConstipationNCT06761443
To Evaluate the Safety and Efficacy of Pediococcus Acidilactici PA53 in Relieving Constipation in Adults
A study testing Probiotic and Maltodextrin in people with Constipation, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
To study the improvement of constipation symptoms, quality of life and mental state, intestinal function, intestinal hormones, inflammation and immunity, and intestinal flora of constipation subjects after 8-week intervention with Pediococcus acidilactici PA53. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Probiotic and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2025to 6 Jun 2025
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-70 years; (2) fewer than three SBMs per week and/or BSFS type 1 or 2; (3) ability to comply with study requirements; (4) provision of signed informed consent; (5) for participants of childbearing potential (including both sexes), agreement to use effective contraception from 14 days before screening until 6 months after study completion.
- -
Who cannot join
- consumption of food or drugs known to affect gastrointestinal function (e.g., laxatives, probiotics) within 4 weeks prior to enrollment; (2) a change in dietary habits within the past month or planned during the study; (3) pregnancy, lactation, or intention to become pregnant; (4) history of severe cardiovascular, pulmonary, hepatic, renal, metabolic (e.g., diabetes, thyroid disease), malignant, or immunological disorders; (5) antibiotic use within 4 weeks prior to the study; (6) severe psychiatric illness; (7) any other condition deemed by the investigators to make the participant unsuitable for the trial.
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nutrition, General Hospital of Ningxia Medical University
Yinchuan, Ningxia
About this study
Official title: Pediococcus Acidilactici PA53 Supplementation Improves Stool Form and Modulates Gut Microbiota and Inflammatory Responses in Adults With Functional Constipation: A Randomized, Double-Blind, Placebo-Controlled Trial
To study the improvement of constipation symptoms, quality of life and mental state, intestinal function, intestinal hormones, inflammation and immunity, and intestinal flora of constipation subjects after 8-week intervention with Pediococcus acidilactici PA53.
- Conditions
- Constipation
- Being tested
- Probiotic, Maltodextrin
- 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 experimental phase of this study had last 8 weeks and each patient will make 3 visits (week 0, week 4, week 8).
MaltodextrinDietary supplement
The experimental phase of this study had last 8 weeks and each patient will make 3 visits (week 0, week 4, week 8).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Every day to Pediococcus acidilactici PA53 (30 billion CFU/day, 3g) intervention, for 8 weeks.
Store in a cool and dry place. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Every day to give 3 g maltodextrin intervention for 8 weeks. Store in a cool and dry place. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation symptom improvement
Assessing the improvement of constipation in patients using the Bristol Stool Form Scale (BSFS) . In this scale, higher scores indicate softer stool textures, closer to liquid consistency. Scores of 4, 5, and 6 are generally considered ideal stool characteristics.
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 posted7 Jan 2025
- Study start3 Jan 2025
- Primary completion3 Jun 2025
- Study completion6 Jun 2025
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
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
- NCT06761443
- Sponsor's protocol ID
- WK2024018
- Status last verified
- Jan 2025
- First submitted
- 1 Jan 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xia Y, Cai Y, Zhang Y, Cai R, Liu H, Qiang Z. Pediococcus acidilacticiPA53 Supplementation Improves Stool Form and Modulates Gut Microbiota and Inflammatory Responses in Adults With Functional Constipation: A Randomized, Double-Blind, Placebo-Controlled Trial. Food Sci Nutr. 2026 Oct 1;14(10):e72370. doi: 10.1002/fsn3.72370. eCollection 2026 Oct.
PubMed 42824822
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediococcus Acidilactici PA53 Supplementation Improves Stool Form and Modulates Gut Microbiota and Inflammatory Responses in Adults With Functional Constipation: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06761443
- Acronym / sponsor ID
- WK2024018
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 7 Jan 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.
To study the improvement of constipation symptoms, quality of life and mental state, intestinal function, intestinal hormones, inflammation and immunity, and intestinal flora of constipation subjects after 8-week intervention with Pediococcus acidilactici PA53.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticEvery day to Pediococcus acidilactici PA53 (30 billion CFU/day, 3g) intervention, for 8 weeks. Store in a cool and dry place. |
| Placebo | Placebo comparator | Dietary Supplement: MaltodextrinEvery day to give 3 g maltodextrin intervention for 8 weeks. Store in a cool and dry place. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18-70 years; (2) fewer than three SBMs per week and/or BSFS type 1 or 2; (3) ability to comply with study requirements; (4) provision of signed informed consent; (5) for participants of childbearing potential (including both sexes), agreement to use effective contraception from 14 days before screening until 6 months after study completion.
- -
Key exclusion criteria (2 listed)
- consumption of food or drugs known to affect gastrointestinal function (e.g., laxatives, probiotics) within 4 weeks prior to enrollment; (2) a change in dietary habits within the past month or planned during the study; (3) pregnancy, lactation, or intention to become pregnant; (4) history of severe cardiovascular, pulmonary, hepatic, renal, metabolic (e.g., diabetes, thyroid disease), malignant, or immunological disorders; (5) antibiotic use within 4 weeks prior to the study; (6) severe psychiatric illness; (7) any other condition deemed by the investigators to make the participant unsuitable for the trial.
- -
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 experimental phase of this study had last 8 weeks and each patient will make 3 visits (week 0, week 4, week 8). | Dietary supplement | Probiotic |
| MaltodextrinThe experimental phase of this study had last 8 weeks and each patient will make 3 visits (week 0, week 4, week 8). | Dietary supplement | Placebo |
Primary outcome
Constipation symptom improvement
Time frame: 8 weeks
Assessing the improvement of constipation in patients using the Bristol Stool Form Scale (BSFS) . In this scale, higher scores indicate softer stool textures, closer to liquid consistency. Scores of 4, 5, and 6 are generally considered ideal stool characteristics.
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 29 Jul 2026.
- Derived from this study: PubMed 42824822Xia Y, Cai Y, Zhang Y, Cai R, Liu H, Qiang Z. Pediococcus acidilacticiPA53 Supplementation Improves Stool Form and Modulates Gut Microbiota and Inflammatory Responses in Adults With Functional Constipation: A Randomized, Double-Blind, Placebo-Controlled Trial. Food Sci Nutr. 2026 Oct 1;14(10):e72370. doi: 10.1002/fsn3.72370. eCollection 2026 Oct.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Maltodextrin 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 2 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 29 Jul 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?
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?
Constipation symptom improvement (time frame: 8 weeks). 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 NCT06761443, 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 29 Jul 2026.