Probiotics and Non-Organic Gastrointestinal Improvement | NCT07081100

Studies
Probiotics and Non-Organic Gastrointestinal Improvement

NCT07081100

Sponsor

Wecare Probiotics Co., Ltd.

Status

Recruiting

Last Update Posted

Jul 31, 2025Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Gastrointestinal Function

Interventions

Probiotic group

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 5, 2025Estimated

Primary Completion Date

Dec 30, 2025Estimated

Completion Date

Mar 1, 2026Estimated

First Submitted Date

Jul 15, 2025

First Submission Date that Met QC Criteria

Jul 15, 2025

First Posted Date

Jul 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2025

Last Update Posted Date

Jul 31, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotic group	Experimental		Dietary Supplement: Probiotic group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotic group	Dietary Supplement	Participants took a freeze-dried probiotic powder every day, half an hour after a meal.	Probiotic group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of gastrointestinal function in study participants	The severity of gastrointestinal symptoms was assessed by the Gastrointestinal Symptom Rating Scale (GSRS). Each item is scored from 1 (no symptoms) to 7 (extremely severe symptoms. Higher scores indicate worse gastrointestinal dysfunction.	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ying Jin, Doctor	Contact	13375163966		sunny13211@sina.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Suzhou Ninth People's Hospital Suzhou Ninth Hospital affiliated to Soochow University	Recruiting	Suzhou	Jiangsu	215200	China