Constipation
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTProbiotics
Probiotics will be administered orally once daily for 8 weeks. Study visits are scheduled at baseline (Week 0), Week 4, and Week 8.
DIETARY_SUPPLEMENTPlacebo
Placebo will be administered orally once daily for 8 weeks. Study visits are scheduled at baseline (Week 0), Week 4, and Week 8.
Sponsors
Wecare Probiotics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
CONTACTYing Jin
Outcome results
None listed