Adults With Constipation

NCT07529457 — Not applicable, Recruiting, 70 participants, Wecare Probiotics Co., Ltd.

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To Evaluate the Efficacy and Safety of Probiotics in Alleviating Constipation in Adults Through a Randomized, Double-blind, Placebo-controlled Trial

Registry	NCT07529457
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	70 (Estimated)
Sponsor	Wecare Probiotics Co., Ltd. (Industry)
Conditions	Constipation
Interventions	Probiotics, Placebo (Dietary supplement)
Dates	start 2026-07-24, primary completion 2027-03-01 (estimated), completion 2027-05-20 (estimated), first posted 2026-04-14, last updated 2026-08-28
Locations	1 site in China

-Summary

This randomized, double-blind, placebo-controlled trial will assess the clinical effects of probiotics in adults with functional constipation. Participants will receive probiotics or placebo for 8 weeks. The study will evaluate changes in bowel habits and symptom burden, as well as alterations in host inflammatory status, immune modulation, microbial ecosystem dynamics, neuroendocrine signaling related to the gut-brain axis, and systemic metabolic responses, to characterize the overall physiological impact of probiotic supplementation.

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+Arms and interventions

Arm	Type	Interventions	Description
Probiotic group	Experimental	Dietary Supplement: Probiotics	Participants assigned to this group will receive probiotics once daily for 8 weeks.
Placebo group	Placebo comparator	Dietary Supplement: Placebo	Participants assigned to this group will receive probiotics once daily for 8 weeks.

Probiotics (Dietary supplement): Probiotics will be administered orally once daily for 8 weeks. Study visits are scheduled at baseline (Week 0), Week 4, and Week 8.
Placebo (Dietary supplement): Placebo will be administered orally once daily for 8 weeks. Study visits are scheduled at baseline (Week 0), Week 4, and Week 8.

+Outcome measures

Primary outcomes

Improvement in bowel function [8 weeks]: Bowel function will be assessed using the Bristol Stool Form Scale (BSFS), with emphasis on the transition of stool types from harder forms (types 1-2) to softer, more normal forms (types 3-4) during the intervention period.

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

1. Men and women aged between 18 and 65 years;
2. Participants presenting with constipation, characterized by <3 spontaneous bowel movements per week or BSFS stool types 1-2;
3. Capable of following the study protocol and completing all required assessments; Individuals who have voluntarily signed the informed consent form;
4. No plans for pregnancy from at least 14 days prior to screening through 6 months after the study, with agreement to use reliable contraception methods.

Exclusion Criteria:

1. Intake of similar functional products within a short period prior to enrollment that could influence study results;
2. Participants who significantly alter their habitual diet during the trial;
3. Individuals with severe allergic conditions or impaired immune function;
4. Women who are pregnant, lactating, or intending to conceive;
5. Patients with serious underlying diseases affecting major organs or metabolic systems;
6. Antibiotic treatment within 2 weeks before enrollment;
7. Individuals with severe mental or psychological disorders;
8. Non-compliance with study requirements, including improper intake or missed follow-ups;
9. Other subjects considered inappropriate for participation by the investigator.

+Locations (1)

Facility	City	Country	Status
Suzhou Ninth People's Hospital	Suzhou, Jiangsu	China	Recruiting