ConstipationNCT06637397
Probiotics for Alleviating Functional Constipation in Adults
A study testing Probiotic in people with Constipation, run by Wecare Probiotics Co., Ltd. at 2 sites in China.
Trial summary
To investigate the clinical effects of probiotics in relieving chronic constipation in adults, and evaluate the improvement of symptoms in patients with constipation as well as their impacts on gastrointestinal function, immunity, and gut microbiota. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 4 Jul 2024to 20 Oct 2024
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chinese adults who met the Rome III diagnostic criteria and were aged ≥20 years;
- patients with chronic constipation (duration of more than 6 months, with less than 3 bowel movements per week and/or Bristol Scale Type 1 and 2);
- patients in whom loose stools were rare without the use of laxatives;
- The criteria for irritable bowel syndrome were insufficient;
- patients that could complete the study according to the requirements of the trial protocol;
- patients that had signed the informed consent form;
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- the study participants (including male subjects) had no fertility plans within 14 days before screening, and would voluntarily take effective contraceptive measures within 6 months after the end of the trial.
- Only those who met all of the above conditions could be selected.
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Who cannot join
- Those who took items with similar functions to the test subjects in the short term, which may have affected their judgment of the results; (2) those who regularly used drugs that affect bowel habits; (3) patients who changed their diet during the study (such as regularly using a high-fiber diet, according to the recommended food score (RFS)); (4) those who were allergic to probiotics or the ingredients used in this study, those with severe immunodeficiency, or those with serious psychological or psychiatric diseases; (5) women who were pregnant, breastfeeding, or planning to become pregnant; (6) those who suffered from diseases that may cause secondary constipation, such as diabetes, thyroid disease, Alzheimer's disease, severe metabolic diseases, malignant tumors, and severe lesions of important organs (cardiovascular, lung, liver, kidney, etc.); (7) those who had used antibiotics in the two weeks prior; (8) those who did not consume the test samples as required, or were not followed up on time, resulting in uncertainty of efficacy; (9) those who had participated in another clinical trial within one month before enrollment; (10) subjects who were judged by other researchers to be unsuitable for participation. Those who met any of the above conditions were not selected.
- -
Trial locations and contacts
2 sites in 1 country.
China2 sites
Henan University of Science and Technology
Luoyang, Henan, 471000
The School of Food and Bioengineering, Henan University of Science and Technolog
Luoyang, Henan, 471000
About this study
Official title: Weizmannia Coagulans BC99 Relieves Constipation Symptoms by Regulating Inflammatory, Neurotransmitter, and Lipid Metabolic Pathways: A Randomized, Double-Blind, Placebo-Controlled Trial
To investigate the clinical effects of probiotics in relieving chronic constipation in adults, and evaluate the improvement of symptoms in patients with constipation as well as their impacts on gastrointestinal function, immunity, and gut microbiota.
- Conditions
- Constipation
- Being tested
- Probiotic, Placebo
- 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
During the intervention, participants can consume BC99 daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed.
PlaceboDietary supplement
During the intervention, participants can consume maltodextrin daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group | Experimental | Participants receive one sachet per day containing probiotic BC99 and maltodextrin (Week 0 to Week8). Receives: Dietary Supplement: Probiotic |
| Placebo Group | Placebo comparator | Participants receive one sachet per day containing maltodextrin only, serving as the placebo(Week 0 to Week8). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention.
Constipation symptoms are measured using Bristol Stool Form Scale (BSFS).
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 posted15 Oct 2024
- Study start4 Jul 2024
- Primary completion2 Oct 2024
- Study completion20 Oct 2024
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.
- 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
- 100 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
- NCT06637397
- Sponsor's protocol ID
- WK2024007
- Status last verified
- Apr 2024
- First submitted
- 27 May 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu Y, Zhou Y, Fan Q, Gao Y, Fang S, Sun Y, Gu S. Weizmannia coagulans BC99 improved intestinal motility and chronic constipation through regulating gut microbiota: a randomized, double-blind, placebo-controlled trial. Eur J Nutr. 2026 Mar 26;65(3):106. doi: 10.1007/s00394-026-03953-5.
PubMed 41886091
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
- Weizmannia Coagulans BC99 Relieves Constipation Symptoms by Regulating Inflammatory, Neurotransmitter, and Lipid Metabolic Pathways: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06637397
- Acronym / sponsor ID
- WK2024007
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 15 Oct 2024 (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 investigate the clinical effects of probiotics in relieving chronic constipation in adults, and evaluate the improvement of symptoms in patients with constipation as well as their impacts on gastrointestinal function, immunity, and gut microbiota.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Experimental | Dietary Supplement: ProbioticParticipants receive one sachet per day containing probiotic BC99 and maltodextrin (Week 0 to Week8). |
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboParticipants receive one sachet per day containing maltodextrin only, serving as the placebo(Week 0 to Week8). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Chinese adults who met the Rome III diagnostic criteria and were aged ≥20 years;
- patients with chronic constipation (duration of more than 6 months, with less than 3 bowel movements per week and/or Bristol Scale Type 1 and 2);
- patients in whom loose stools were rare without the use of laxatives;
- The criteria for irritable bowel syndrome were insufficient;
- patients that could complete the study according to the requirements of the trial protocol;
Key exclusion criteria (2 listed)
- Those who took items with similar functions to the test subjects in the short term, which may have affected their judgment of the results; (2) those who regularly used drugs that affect bowel habits; (3) patients who changed their diet during the study (such as regularly using a high-fiber diet, according to the recommended food score (RFS)); (4) those who were allergic to probiotics or the ingredients used in this study, those with severe immunodeficiency, or those with serious psychological or psychiatric diseases; (5) women who were pregnant, breastfeeding, or planning to become pregnant; (6) those who suffered from diseases that may cause secondary constipation, such as diabetes, thyroid disease, Alzheimer's disease, severe metabolic diseases, malignant tumors, and severe lesions of important organs (cardiovascular, lung, liver, kidney, etc.); (7) those who had used antibiotics in the two weeks prior; (8) those who did not consume the test samples as required, or were not followed up on time, resulting in uncertainty of efficacy; (9) those who had participated in another clinical trial within one month before enrollment; (10) subjects who were judged by other researchers to be unsuitable for participation. Those who met any of the above conditions were not selected.
- -
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 |
|---|---|---|
| ProbioticDuring the intervention, participants can consume BC99 daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed. | Dietary supplement | Probiotic Group |
| PlaceboDuring the intervention, participants can consume maltodextrin daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed. | Dietary supplement | Placebo Group |
Primary outcome
Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention.
Time frame: 8 weeks
Constipation symptoms are measured using Bristol Stool Form Scale (BSFS).
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 41886091Wu Y, Zhou Y, Fan Q, Gao Y, Fang S, Sun Y, Gu S. Weizmannia coagulans BC99 improved intestinal motility and chronic constipation through regulating gut microbiota: a randomized, double-blind, placebo-controlled trial. Eur J Nutr. 2026 Mar 26;65(3):106. doi: 10.1007/s00394-026-03953-5.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Constipation, run by Wecare Probiotics Co., Ltd. at 2 sites 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 9 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 2 sites 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?
Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention. (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 NCT06637397, 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.