CClinicalTrials.gg
RecruitingNCT07529457Updated Aug 28, 2026

Adults With Constipation

An interventional study of Probiotics 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 2026-08-28.

Sponsored by Wecare Probiotics Co., Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Constipation

Browse trials for

03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Probiotic group

    Participants assigned to this group will receive probiotics once daily for 8 weeks.

    Dietary Supplement: Probiotics

  • Placebo comparator
    Placebo group

    Participants assigned to this group will receive probiotics once daily for 8 weeks.

    Dietary Supplement: Placebo

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.

05

What researchers measure

Primary outcomes

  1. Improvement in bowel function

    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.

    Time frame: 8 weeks

06

Study locations

1 of 1 sites recruiting
  • Suzhou Ninth People's Hospital
    Suzhou, Jiangsu 215000, China
    Recruiting
07

Registry details

Key details

Study ID
NCT07529457
Lead sponsor
Wecare Probiotics Co., Ltd.
Responsible party
Sponsor
First posted
Apr 14, 2026
Start date
Jul 24, 2026
Primary completion
Mar 1, 2027 (estimated)
Completion
May 20, 2027 (estimated)
Last update
Aug 28, 2026

Study contacts

Ying Jin
Contact
1959643812@qq.com
18336086291

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion