ConstipationNCT07765004
Probiotics Improve Constipation
A study testing Probitics in people with Constipation, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
This study is a randomized, double-blind, placebo-controlled trial in which adult subjects with constipation are randomly assigned to either a probiotic group or a placebo group for an 8-week intervention. 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?
- Probitics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2026to 20 Dec 2026
- 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
- Aged 18 to 65 years (inclusive).
- Diagnosed with constipation, defined as fewer than 3 spontaneous bowel movements per week and/or Bristol Stool Form Scale types 1 or 2.
- Willing and able to comply with the study protocol and complete all required assessments.
- Provide written informed consent prior to any study-related procedures.
- Male and female participants of childbearing potential must agree to use effective contraception voluntarily from 14 days prior to screening until 6 months after the end of the trial. Female participants of non-childbearing potential (e.g., post-menopausal or surgically sterile) are exempt from this requirement.
Who cannot join
- Use of products with functions similar to the investigational product within a short period prior to screening that may interfere with the evaluation of study outcomes.
- Intention to change dietary habits significantly during the study period.
- Severe allergies or immunodeficiency.
- Women who are pregnant, breastfeeding, or planning to become pregnant during the trial.
- Severe diseases of vital organs (including cardiovascular, pulmonary, hepatic, or renal disease), metabolic diseases (e.g., diabetes, thyroid disorders), malignancy, or severe immune system disorders.
- Use of antibiotics within the past 30 days.
Show all 13Show fewer
- Severe psychological or psychiatric disorders.
- Poor compliance (e.g., failure to take the test product as instructed or failure to attend scheduled follow-up visits) that would preclude a valid assessment of efficacy.
- Organic constipation (e.g., caused by structural or pathological conditions).
- Irritable bowel syndrome with constipation (IBS-C).
- History of surgical procedures within 30 days prior to screening that may have caused or contributed to constipation symptoms.
- Intake of probiotic or prebiotic supplements within one month prior to the start of the study.
- Any other condition that, in the investigator's opinion, would make the participant unsuitable for participation in the study.
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, +86 18336086291, 1959643812@qq.com
About this study
Official title: Safety and Efficacy of Probiotics for Constipation Relief in Adults: A Randonmized, Double-blind, Placebo-controlled Trial
This study is a randomized, double-blind, placebo-controlled trial in which adult subjects with constipation are randomly assigned to either a probiotic group or a placebo group for an 8-week intervention. Through blood and fecal sample analyses combined with multidimensional questionnaire assessments, the study aims to systematically evaluate the efficacy of probiotics in improving gastrointestinal function, immune status, and mental health in patients with constipation.
- Conditions
- Constipation
- Being tested
- Probitics, Placebo
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbiticsDietary 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 1, Week 2, 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 1, Week 2, Week 4, and Week 8.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics Group | Experimental | Participants receive one sachet (1g) of probiotic powder containing 2.0 × 10¹⁰ CFU per sachet, taken orally once daily for 8 weeks. Receives: Dietary Supplement: Probitics |
| Placebo Group | Placebo comparator | Matching placebo powder (maltodextrin), identical in appearance, taste, and weight to the probiotic powder, administered orally once daily for 8 weeks. Receives: Dietary Supplement: Placebo |
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: Baseline, Week 1, Week 2, Week 4, Week 8
Change in Spontaneous Bowel Movement (SBM) Frequency
Change from baseline in number of spontaneous bowel movements. Spontaneous bowel movements are defined as bowel movements occurring without the use of laxatives, enemas, or suppositories within the previous 24 hours.
Measured: Baseline, Week 1, Week 2, Week 4, Week 8
Secondary outcomes (9)
Change in Gastrointestinal Symptom Rating Scale (GSRS) Score
Change from baseline in GSRS total and subscale scores. GSRS is a 15-item questionnaire assessing gastrointestinal symptoms across 5 domains (reflux, abdominal pain, indigestion, diarrhea, constipation), each rated on a 7-point Likert scale. Higher scores indicate more severe symptoms.
Measured: Baseline, Week 1, Week 2, Week 4, Week 8
Change in Patient Assessment of Constipation Symptoms (PAC-SYM) Score
Change from baseline in PAC-SYM total score. PAC-SYM is a 12-item questionnaire assessing constipation-related symptoms across 3 subscales (abdominal, rectal, stool), each rated on a 5-point Likert scale. Higher scores indicate more severe symptoms.
Measured: Baseline, Week 1, Week 2, Week 4, Week 8
Change in Patient Assessment of Constipation Quality of Life (PAC-QOL) Score
Change from baseline in PAC-QOL total score. PAC-QOL is a 28-item questionnaire assessing quality of life related to constipation across 4 domains (physical discomfort, psychosocial discomfort, worries/concerns, satisfaction), each rated on a 5-point Likert scale. Higher scores indicate poorer quality of life.
Measured: Baseline, Week 1, Week 2, Week 4, Week 8
Change in Depression, Anxiety, and Stress Scale-21 (DASS-21) Score
Change from baseline in DASS-21 total and subscale scores. DASS-21 is a 21-item questionnaire assessing depression, anxiety, and stress across 3 domains, each rated on a 4-point Likert scale. Higher scores indicate more severe psychological distress.
Measured: Baseline, Week 1, Week 2, Week 4, Week 8
Change in Serum Inflammatory and Immune Markers
Change from baseline in serum levels of interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor-alpha (TNF-α), and interferon-gamma (IFN-γ).
Measured: Baseline, Week 8
Change in Serum Gut-Brain Axis Regulatory Markers
Change from baseline in serum levels of 5-hydroxytryptamine (5-HT), motilin (MTL), and substance P (SP).
Measured: Baseline, Week 8
Change in Serum Intestinal Barrier Function Markers
Change from baseline in serum levels of occludin, zonula occludens-1 (ZO-1), and lipopolysaccharide (LPS).
Measured: Baseline, Week 8
Change in Serum Digestive Enzyme Levels
Change from baseline in serum levels of pepsin, trypsin, and lipase.
Measured: Baseline, Week 8
Change in Gut Microbiota Composition
Change from baseline in gut microbiota diversity (alpha and beta diversity) and taxonomic composition at phylum and genus levels, assessed by 16S rRNA sequencing of fecal samples.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start7 Aug 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion20 Dec 2026 (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
- 76 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
- NCT07765004
- Sponsor's protocol ID
- WK20260801
- Status last verified
- Jul 2026
- First submitted
- 10 Aug 2026
- Last updated
- 17 Aug 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 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Probiotics for Constipation Relief in Adults: A Randonmized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07765004
- Acronym / sponsor ID
- WK20260801
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 14 Aug 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 is a randomized, double-blind, placebo-controlled trial in which adult subjects with constipation are randomly assigned to either a probiotic group or a placebo group for an 8-week intervention. Through blood and fecal sample analyses combined with multidimensional questionnaire assessments, the study aims to systematically evaluate the efficacy of probiotics in improving gastrointestinal function, immune status, and mental health in patients with constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics Group | Experimental | Dietary Supplement: ProbiticsParticipants receive one sachet (1g) of probiotic powder containing 2.0 × 10¹⁰ CFU per sachet, taken orally once daily for 8 weeks. |
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboMatching placebo powder (maltodextrin), identical in appearance, taste, and weight to the probiotic powder, administered orally 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)
- Aged 18 to 65 years (inclusive).
- Diagnosed with constipation, defined as fewer than 3 spontaneous bowel movements per week and/or Bristol Stool Form Scale types 1 or 2.
- Willing and able to comply with the study protocol and complete all required assessments.
- Provide written informed consent prior to any study-related procedures.
- Male and female participants of childbearing potential must agree to use effective contraception voluntarily from 14 days prior to screening until 6 months after the end of the trial. Female participants of non-childbearing potential (e.g., post-menopausal or surgically sterile) are exempt from this requirement.
Key exclusion criteria (13 listed)
- Use of products with functions similar to the investigational product within a short period prior to screening that may interfere with the evaluation of study outcomes.
- Intention to change dietary habits significantly during the study period.
- Severe allergies or immunodeficiency.
- Women who are pregnant, breastfeeding, or planning to become pregnant during the trial.
- Severe diseases of vital organs (including cardiovascular, pulmonary, hepatic, or renal disease), metabolic diseases (e.g., diabetes, thyroid disorders), malignancy, or severe immune system disorders.
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 |
|---|---|---|
| ProbiticsThe 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 1, Week 2, Week 4, and Week 8. | Dietary supplement | Probiotics 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 1, Week 2, Week 4, and Week 8. | Dietary supplement | Placebo Group |
Primary outcome
Improvement of constipation symptoms
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8
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).
Change in Spontaneous Bowel Movement (SBM) Frequency
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8
Change from baseline in number of spontaneous bowel movements. Spontaneous bowel movements are defined as bowel movements occurring without the use of laxatives, enemas, or suppositories within the previous 24 hours.
9 secondary outcomes
Change in Gastrointestinal Symptom Rating Scale (GSRS) Score
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8
Change in Patient Assessment of Constipation Symptoms (PAC-SYM) Score
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8
Change in Patient Assessment of Constipation Quality of Life (PAC-QOL) Score
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8
Change in Depression, Anxiety, and Stress Scale-21 (DASS-21) Score
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8
Change in Serum Inflammatory and Immune Markers
Time frame: Baseline, Week 8
Change in Serum Gut-Brain Axis Regulatory Markers
Time frame: Baseline, Week 8
Change in Serum Intestinal Barrier Function Markers
Time frame: Baseline, Week 8
Change in Serum Digestive Enzyme Levels
Time frame: Baseline, Week 8
Change in Gut Microbiota Composition
Time frame: Baseline, Week 8
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 17 Aug 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 Probitics 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 5 inclusion and 13 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 17 Aug 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, Doctor (+86 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: Baseline, Week 1, Week 2, Week 4, 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 Aug 2026.