ClinicalTrials.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

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
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

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03

In context

Constipation

1,046 studies on the registry are indexed under Constipation; 161 are open to participants now.

This study's planned enrollment of 70 is close to the median of 75 across 884 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Wecare Probiotics Co., Ltd. is the lead sponsor of 67 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

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.

06

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

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07529457
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 ↗

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