An interventional study of Probitics and Placebo in Constipation, sponsored by Wecare Probiotics Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Wecare Probiotics Co., Ltd. · Not applicable, Interventional, and Treatment
Among 10 studies in Constipation by Wecare Probiotics Co., Ltd. — 5 open to participants now, 5 under way, none of them phase 3. Constipation · Wecare Probiotics Co., Ltd..
Among the 10 studies in Constipation by Wecare Probiotics Co., Ltd., this one is the 8th largest by planned enrollment, is one of 4 that started in 2026, is one of 10 with no phase, and was the 10th registered.
1,046 studies on the registry are indexed under Constipation; 161 are open to participants now.
This study's planned enrollment of 76 is close to the median of 75 across 884 interventional studies indexed under Constipation.
Browse Constipation studies →5 of the 10 studies in Constipation by Wecare Probiotics Co., Ltd. are open now, in 1 country. Each count lists the studies.
Of the 98 Constipation studies recruiting now, 32 (33%) set no upper age limit and 51 (52%) stop at 75 or younger; 16 take children under 18; 28 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2021; this study’s year is marked. 4 started in 2026.
Median enrollment 86 across the 10 interventional studies. Of the 5 that completed or were terminated, 0 (0%) have results posted.
Wecare Probiotics Co., Ltd. is the lead sponsor of 67 studies on the registry; 23 are open to participants now.
4 of the studies in Constipation by Wecare Probiotics Co., Ltd. that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07507955Wecare Probiotics Co., Ltd.Probiotics for Constipation Relief in Adults | 2026-11-30 |
| NCT07765004Wecare Probiotics Co., Ltd.Probiotics Improve Constipation | 2026-12-15 |
| NCT07529457Wecare Probiotics Co., Ltd.Adults With Constipation | 2027-03-01 |
| NCT07462481Wecare Probiotics Co., Ltd.Probiotic Improve Constipation | 2027-06-01 |
Among the 10 studies in Constipation by Wecare Probiotics Co., Ltd., from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive one sachet (1g) of probiotic powder containing 2.0 × 10¹⁰ CFU per sachet, taken orally once daily for 8 weeks.
Dietary Supplement: Probitics
Matching placebo powder (maltodextrin), identical in appearance, taste, and weight to the probiotic powder, administered orally once daily for 8 weeks.
Dietary Supplement: Placebo
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.
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.
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).
Time frame: 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.
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline, Week 8
Change in Serum Digestive Enzyme Levels
Change from baseline in serum levels of pepsin, trypsin, and lipase.
Time frame: 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.
Time frame: Baseline, Week 8
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