RECRUITING Not applicable ClinicalTrials.gov

Adults With Constipation

Sponsor: Wecare Probiotics Co., Ltd. • ClinicalTrials.gov ID: NCT07529457

Registry updated: 2026-08-28

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Description

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.

Interventions

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.

Eligibility criteria

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.

Conditions

Constipation

Locations

Suzhou Ninth People's Hospital — Suzhou, Jiangsu, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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