ClinicalTrials.gg
RecruitingNCT07462481Updated Jun 9, 2026

Probiotic Improve Constipation

An interventional study of Probiotic 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 2026-06-09.

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

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

To evaluate the efficacy and safety of probiotic as a food supplement in regulating bowel habits in patients with chronic constipation, and to compare it with placebo.

02

Conditions studied

  • Constipation

Browse trials for

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 105 is above 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) Age 18-65 years; (2) Constipated patients (less than 3 bowel movements per week and/or Bristol Scale type 1 and 2); (3) Able to complete the study according to the trial protocol; (4) Patients who have signed the form; (5) Study participants (including male study participants) have no plans to have children within 14 days prior to screening and within 6 months after the end of the trial and voluntarily use effective .

-

Exclusion criteria

Exclusion Criteria:

  1. Those who have taken a substance with a similar function to the test subject in a short period of time, affecting their judgment of the results;
  2. Patients who changed their diet during the study;
  3. Patients with severe allergies and immunodeficiency;
  4. Pregnant, breastfeeding, or women planning to become pregnant;
  5. Those with severe diseases of vital organs such as the cardiovascular system, lungs, liver, and kidneys, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, or severe immune system diseases;
  6. Those who have used antibiotics in the past two weeks;
  7. Those with severe psychological or mental illnesses;
  8. Those who did not consume the test sample as required or did not follow up on time, resulting in the inability to determine the efficacy;
  9. Other study participants deemed unsuitable by the researchers. -
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
Double (Participant, Investigator)
Enrollment
105 participants (estimated)

Study arms

  • Experimental
    Probiotic Group

    Taking 60 billion CFU of Lactobacillus plantarum Lp18 daily; Storage: Store in a cool, dry palce without sun expouse.

    Dietary Supplement: Probiotic

  • Placebo comparator
    Placebo Group

    Take 3g of maltodextrin daily; the product packaging is the same as that of probiotic products.

    Dietary Supplement: Placebo

  • Experimental
    High-activity probiotic group

    Taking 300 billion CFU of Lactobacillus plantarum Lp18 daily; Storage: Store in a cool, dry palce without sun expouse.

    Dietary Supplement: High-activity probiotic probiotic

Interventions

  • Dietary supplementProbiotic

    The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8.

  • Dietary supplementPlacebo

    The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8.

  • Dietary supplementHigh-activity probiotic probiotic

    The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8.

06

What researchers measure

Primary outcomes

  1. Improvement of constipation symptoms

    Improvement in constipation was assessed using the Bristol Stool Characteristics Scale (BSFS), primarily observing the shift in stool type from type 1-2 (hard stool/constipation) to type 3-4 (normal/ideal soft stool).

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Jun 2027, 11 months later.

Of 71 industry-sponsored interventional studies with no phase under Constipation, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's planned 11 months is close to that.

Counting every sponsor, half of 314 studies reached it within 14 months; a quarter within 6 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 4, 2026
First posted
Mar 10, 2026
StartEst.
Jun 10, 2026
Primary completionEst.
Jun 1, 2027
CompletionEst.
Aug 1, 2027
Last update
Jun 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07462481
Responsible party
Sponsor
First posted
Mar 10, 2026
Start date
Jun 10, 2026 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Jun 9, 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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Studies of the drug tested here: Probiotic

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