Probiotic Intervention in Constipation

NCT07462494 | Not Yet Recruiting

• 1 other identifier: WK20260304
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gastrointestinal Function

Outcome Measures

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.

  8 weeks

Study Arms (3)

Probiotic group A

EXPERIMENTAL

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

Dietary Supplement: GUT99 1

Placebo group

PLACEBO COMPARATOR

Maltodextrin powder administered orally once daily for 8 weeks.

Dietary Supplement: Placebo

Probiotic group B

EXPERIMENTAL

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

Dietary Supplement: GUT99 2

Interventions

GUT99 1 DIETARY_SUPPLEMENT

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

Probiotic group A

GUT99 2 DIETARY_SUPPLEMENT

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

Probiotic group B

Placebo DIETARY_SUPPLEMENT

Taken orally once daily for 8 weeks.

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Central Study Contacts

Ying Jin, Doctor

CONTACT

13375163966; sunny13211@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06