ConstipationNCT06879587
Probiotics Alleviate Functional Constipation in Adults
A study testing Probiotic in people with Constipation, run by Wecare Probiotics Co., Ltd. at 1 site 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 18 to 70 yearsHealthy 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
- 84 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2024to 17 Dec 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chinese adults aged 18-70 who meet the following Rome-IV diagnostic criteria for Functional constipation:
- If the following symptoms started at least 6 months ago and have been present for the past 3 months with two or more of the following:
- Straining during more than 25% of defecations
- Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than 25% of defecations
- Sensation of incomplete evacuation more than 25% of defecations
- Sensation of anorectal obstruction/blockage more than 25% of defecations
Show all 12Show fewer
- Manual maneuvers to facilitate more than 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
- Fewer than three SBM per week ii Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome.
- Able to complete the study according to the requirements of the trial protocol;
- Patients who have signed the informed consent form;
- Research participants (including male participants) who have no fertility plans from 14 days before screening until 6 months after the end of the trial and are willing to take effective contraceptive measures.
- Only those who meet all the above conditions can be selected for the study. -
Who cannot join
- The use of probiotics, prebiotics, or antibiotics within 2 weeks of enrollment.
- Regular use of a high-fiber diet, as measured by the recommended food score (RFS);
- Regular use of medications affecting bowel habits, such as irritable bowel syndrome, functional bloating, and functional diarrhea.
- Currently have, or have had in the past 2 years, any gastrointestinal conditions such as: Crohn's disease, celiac disease, Ulcerative colitis, Malignant tumor of the colon.
- Medical history of cardiovascular, liver, or renal diseases; alcoholics.
- Hypersensitivity to probiotics or the ingredients used in this study.
- Pregnancy or breastfeeding.
- Participation in another clinical trial in the 3 months before enrollment. All participants provided written informed consent. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Safety and Effectiveness of Bacillus Coagulans BC99 in Relieving Functional Constipation in Adults Based on Randomized, Double-Blind, Placebo-Controlled Trials
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 could take BC99 daily and record any adverse reactions. Participants filled out questionnaires and collected stool and serum samples, which were used to detect and analyze the improvement of participants' constipation function.
PlaceboDietary supplement
During the intervention, participants could take maltodextrin daily and record any adverse reactions. Participants filled out questionnaires and collected stool and serum samples, which were used to detect and analyze the improvement of participants' constipation function.
| 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.
Change in colonic transit time (CTT) from baseline to 8 weeks
Colonic transit time (hours) was measured by radiolabmarking, and the reduction from baseline was an indicator of effectiveness.
Measured: Week 0 and Week 8
Change in Patient Assessment of Constipation Symptoms (PAC-SYM) score from baseline to 8 weeks.
The PAC-SYM questionnaire was used to assess the severity of constipation symptoms (12 items, 0-4 Likert score), with a total score ranging from 0-48 (the lower the score, the milder the symptoms). The magnitude of the decline from the baseline score is an indicator of effectiveness.
Measured: Week 0 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start8 Sep 2024
- Primary completion7 Oct 2024
- Study completion17 Dec 2024
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
- 84 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
- NCT06879587
- Sponsor's protocol ID
- WK2024019
- Status last verified
- Sep 2024
- First submitted
- 5 Mar 2025
- Last updated
- 17 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 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Safety and Effectiveness of Bacillus Coagulans BC99 in Relieving Functional Constipation in Adults Based on Randomized, Double-Blind, Placebo-Controlled Trials
- ClinicalTrials.gov ID
- NCT06879587
- Acronym / sponsor ID
- WK2024019
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2024 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 17 Mar 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 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
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Chinese adults aged 18-70 who meet the following Rome-IV diagnostic criteria for Functional constipation:
- Able to complete the study according to the requirements of the trial protocol;
- Patients who have signed the informed consent form;
- Research participants (including male participants) who have no fertility plans from 14 days before screening until 6 months after the end of the trial and are willing to take effective contraceptive measures.
- Only those who meet all the above conditions can be selected for the study. -
Key exclusion criteria (8 listed)
- The use of probiotics, prebiotics, or antibiotics within 2 weeks of enrollment.
- Regular use of a high-fiber diet, as measured by the recommended food score (RFS);
- Regular use of medications affecting bowel habits, such as irritable bowel syndrome, functional bloating, and functional diarrhea.
- Currently have, or have had in the past 2 years, any gastrointestinal conditions such as: Crohn's disease, celiac disease, Ulcerative colitis, Malignant tumor of the colon.
- Medical history of cardiovascular, liver, or renal diseases; alcoholics.
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 could take BC99 daily and record any adverse reactions. Participants filled out questionnaires and collected stool and serum samples, which were used to detect and analyze the improvement of participants' constipation function. | Dietary supplement | Probiotic Group |
| PlaceboDuring the intervention, participants could take maltodextrin daily and record any adverse reactions. Participants filled out questionnaires and collected stool and serum samples, which were used to detect and analyze the improvement of participants' constipation function. | Dietary supplement | Placebo Group |
Primary outcome
Change in colonic transit time (CTT) from baseline to 8 weeks
Time frame: Week 0 and Week 8
Colonic transit time (hours) was measured by radiolabmarking, and the reduction from baseline was an indicator of effectiveness.
Change in Patient Assessment of Constipation Symptoms (PAC-SYM) score from baseline to 8 weeks.
Time frame: Week 0 and Week 8
The PAC-SYM questionnaire was used to assess the severity of constipation symptoms (12 items, 0-4 Likert score), with a total score ranging from 0-48 (the lower the score, the milder the symptoms). The magnitude of the decline from the baseline score is an indicator of effectiveness.
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 17 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. 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 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 12 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: finished, as of the sponsor's last update on 17 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?
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?
Change in colonic transit time (CTT) from baseline to 8 weeks (time frame: Week 0 and Week 8). The study lists 2 primary outcomes in all. 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 17 Mar 2025.