ClinicalTrials.gg
Not yet recruitingNCT07462494Updated Jun 9, 2026

Probiotic Intervention in Constipation

An interventional study of GUT99 1 and Placebo in Gastrointestinal Function, sponsored by Wecare Probiotics Co., Ltd.. Not yet recruiting. 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
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

To evaluate the effects of probiotic intervention on gastrointestinal function in patients with constipation after 4 weeks of treatment, and to explore its potential effects on immune status and bone metabolism.

02

Conditions studied

  • Gastrointestinal Function
03

In context

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. Aged 18-65 years.
  2. Patients with constipation, defined as fewer than three bowel movements per week and/or Bristol Stool Form Scale (BSFS) types 1-2.
  3. Able to comply with the study protocol and complete the study procedures.
  4. Participants who have voluntarily signed the form.
  5. Participants (including male participants) must have no plans for pregnancy from 14 days before screening until 6 months after the end of the study and must agree to use effective during this period.

    -

Exclusion criteria

Exclusion Criteria:

  1. Individuals who have recently taken products with similar functions to the product that may affect the evaluation of study outcomes.
  2. Participants who plan to change their dietary habits during the study period.
  3. Patients with severe allergies or immunodeficiency.
  4. Women who are pregnant, breastfeeding, or planning to become pregnant.
  5. Patients with severe diseases of major organs such as the cardiovascular system, lungs, liver, or kidneys, or those with severe metabolic diseases (e.g., diabetes or thyroid disorders), malignant tumors, or severe immune system diseases.
  6. Individuals who have used antibiotics within the past two weeks.
  7. Individuals with severe psychological or psychiatric disorders.
  8. Participants who fail to take the investigational product as required or fail to attend scheduled follow-up visits, resulting in an inability to determine treatment efficacy.
  9. Any other participants considered unsuitable for participation in the study by the investigator.

    -

Terms in these criteria, in plain language(3)

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.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

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

Study arms

  • Experimental
    Probiotic group A

    Probiotic powder containing GUT99 (1000B) administered orally once daily for 8 weeks.

    Dietary Supplement: GUT99 1

  • Placebo comparator
    Placebo group

    Maltodextrin powder administered orally once daily for 8 weeks.

    Dietary Supplement: Placebo

  • Experimental
    Probiotic group B

    Probiotic powder containing GUT99 (120B) administered orally once daily for 8 weeks.

    Dietary Supplement: GUT99 2

Interventions

  • Dietary supplementGUT99 1

    Taken orally once daily for 8 weeks (120B).

  • Dietary supplementPlacebo

    Taken orally once daily for 8 weeks.

  • Dietary supplementGUT99 2

    Taken orally once daily for 8 weeks (1000B).

06

What researchers measure

Primary outcomes

  1. Changes in stool consistency

    Stool consistency will be evaluated using the Bristol Stool Form Scale (BSFS) to assess the improvement of constipation symptoms in patients receiving probiotic intervention.

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2026; primary completion for Dec 2026, 5 months later.

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.
Dec 1, 2026
CompletionEst.
Dec 30, 2026
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
NCT07462494
Responsible party
Sponsor
First posted
Mar 10, 2026
Start date
Jun 10, 2026 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Jun 9, 2026

Study contacts

Ying Jin, Doctor
Contact
sunny13211@sina.com
13375163966

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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