Probiotics for constipation in adults
Official title: Safety and Efficacy of Probiotics for Constipation Relief in Adults: A Randonmized, Double-blind, Placebo-controlled Trial
Run by Wecare Probiotics Co., Ltd. · NCT07765004 · Data updated 2026-11-12
This randomized, placebo-controlled study tests whether probiotics can help adults with constipation, compared with a placebo over 8 weeks.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 76 (estimated) |
| Sponsor | Wecare Probiotics Co., Ltd. Industry-sponsored |
| Locations | 1 site (Suzhou, Jiangsu) |
| Status | Recruiting |
| Started | August 7, 2026 |
| Main results expected | December 15, 2026 |
| Study ends | December 20, 2026 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT07765004 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with constipation defined as fewer than 3 spontaneous bowel movements per week and/or Bristol Stool Form Types 1–2.
✕Probably not a fit
Individuals without a response to probiotics in prior research or with conditions that exclude probiotic efficacy may see no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial is an randomized, double-blind, placebo-controlled study enrolling adults with constipation. Participants are assigned to receive either a probiotic product or a placebo for 8 weeks. Outcomes include measurements from blood and stool samples as well as multidimensional questionnaires to assess gut function, immune status, and mental well-being. The study aims to determine whether probiotic use can improve gastrointestinal symptoms and related health aspects in this population.
Why it matters
Potential benefit: If successful, participants may experience improved bowel function and related health effects from probiotic use.
How similar studies have gone: Previous probiotic studies in constipation have shown mixed results, making this trial an important test of whether this approach can help this group.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
Where it's running
-
Suzhou Ninth People's Hospital
Suzhou, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Ying Jin, Doctor
- Email: 1959643812@qq.com
- Phone: +86 18336086291
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.