Probiotics and Non-Organic Gastrointestinal Improvement

NCT ID: NCT07081100

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-05

Study Completion Date

2026-03-01

Brief Summary

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To verify the improvement of gastrointestinal function in patients with non-organic gastrointestinal dysfunction after 4 weeks of intervention with compound probiotics.

Detailed Description

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Conditions

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Gastrointestinal Function

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Probiotic group

Group Type EXPERIMENTAL

Probiotic group

Intervention Type DIETARY_SUPPLEMENT

Participants took a freeze-dried probiotic powder every day, half an hour after a meal.

Interventions

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Probiotic group

Participants took a freeze-dried probiotic powder every day, half an hour after a meal.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Voluntarily sign the informed consent form and agree to participate in the study.
* Ability to complete the study according to the trial protocol requirements.
* Aged 18-65 years.
* Clinical diagnosis of non-organic gastrointestinal dysfunction (e.g., functional dyspepsia, functional constipation) without other serious organic diseases.

Exclusion Criteria

* Use of drugs affecting intestinal flora (antibiotics, probiotics, intestinal mucosal protectants, herbal medicines, etc.) for \>1 week within 1 month prior to screening.
* Short-term use of products with functions similar to the investigational product, which may interfere with result interpretation.
* Antibiotic use during the study period.
* History of severe systemic diseases or malignancies.
* Allergy to any ingredient in the compound probiotic freeze-dried powder used in the trial.
* Pregnancy, lactation, or plans for pregnancy in the near future.
* Inability to participate due to personal reasons.
* Other conditions deemed unsuitable by the investigators.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Suzhou Ninth People's Hospital Suzhou Ninth Hospital affiliated to Soochow University

Suzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ying Jin, Doctor

Role: CONTACT

13375163966

Facility Contacts

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Ying Jin, Doctor

Role: primary

Other Identifiers

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WK20250716

Identifier Type: -

Identifier Source: org_study_id

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