Gastrointestinal FunctionNCT07462494
Probiotic Intervention in Constipation
A study testing GUT99 1 and GUT99 2 in people with Gastrointestinal Function, run by Wecare Probiotics Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Function
- What is being tested?
- GUT99 1 and GUT99 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-65 years.
- Patients with constipation, defined as fewer than three bowel movements per week and/or Bristol Stool Form Scale (BSFS) types 1-2.
- Able to comply with the study protocol and complete the study procedures.
- Participants who have voluntarily signed the informed consent form.
- 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 contraception during this period.
- -
Who cannot join
- Individuals who have recently taken products with similar functions to the investigational product that may affect the evaluation of study outcomes.
- Participants who plan to change their dietary habits during the study period.
- Patients with severe allergies or immunodeficiency.
- Women who are pregnant, breastfeeding, or planning to become pregnant.
- 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.
- Individuals who have used antibiotics within the past two weeks.
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- Individuals with severe psychological or psychiatric disorders.
- 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.
- Any other participants considered unsuitable for participation in the study by the investigator.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: To Evaluate the Efficacy and Safety of Probiotics in Alleviating Constipation in Adults Through a Randomized, Double-blind, Placebo-controlled Trial
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.
- Conditions
- Gastrointestinal Function
- Being tested
- GUT99 1, Placebo, GUT99 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GUT99 1Dietary supplement
Taken orally once daily for 8 weeks (120B).
PlaceboDietary supplement
Taken orally once daily for 8 weeks.
GUT99 2Dietary supplement
Taken orally once daily for 8 weeks (1000B).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group A | Experimental | Probiotic powder containing GUT99 (1000B) administered orally once daily for 8 weeks. Receives: Dietary Supplement: GUT99 1 |
| Placebo group | Placebo comparator | Maltodextrin powder administered orally once daily for 8 weeks. Receives: Dietary Supplement: Placebo |
| Probiotic group B | Experimental | Probiotic powder containing GUT99 (120B) administered orally once daily for 8 weeks. Receives: Dietary Supplement: GUT99 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start10 Jun 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462494
- Sponsor's protocol ID
- WK20260304
- Status last verified
- Jun 2026
- First submitted
- 4 Mar 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Efficacy and Safety of Probiotics in Alleviating Constipation in Adults Through a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07462494
- Acronym / sponsor ID
- WK20260304
- Conditions
- Gastrointestinal Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic group A | Experimental | Dietary Supplement: GUT99 1Probiotic powder containing GUT99 (1000B) administered orally once daily for 8 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin powder administered orally once daily for 8 weeks. |
| Probiotic group B | Experimental | Dietary Supplement: GUT99 2Probiotic powder containing GUT99 (120B) administered orally once daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-65 years.
- Patients with constipation, defined as fewer than three bowel movements per week and/or Bristol Stool Form Scale (BSFS) types 1-2.
- Able to comply with the study protocol and complete the study procedures.
- Participants who have voluntarily signed the informed consent form.
- 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 contraception during this period.
Key exclusion criteria (10 listed)
- Individuals who have recently taken products with similar functions to the investigational product that may affect the evaluation of study outcomes.
- Participants who plan to change their dietary habits during the study period.
- Patients with severe allergies or immunodeficiency.
- Women who are pregnant, breastfeeding, or planning to become pregnant.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GUT99 1Taken orally once daily for 8 weeks (120B). | Dietary supplement | Probiotic group A |
| PlaceboTaken orally once daily for 8 weeks. | Dietary supplement | Placebo group |
| GUT99 2Taken orally once daily for 8 weeks (1000B). | Dietary supplement | Probiotic group B |
Primary outcome
Changes in stool consistency
Time frame: 8 weeks
Stool consistency will be evaluated using the Bristol Stool Form Scale (BSFS) to assess the improvement of constipation symptoms in patients receiving probiotic intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing GUT99 1 and GUT99 2 in people with Gastrointestinal Function, run by Wecare Probiotics Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Jin, Doctor (13375163966, sunny13211@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in stool consistency (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.