The Impact of Compound Probiotic Freeze-dried Powder on Enhancing Gastrointestinal Health

NCT ID: NCT07025798

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-30
• Study Completion Date: 2025-06-12

Brief Summary

The primary objective of this study is to evaluate the effects of the compound probiotic freeze-dried powder on gastrointestinal function and its impact on gut microbiota, immune factors, inflammatory markers, and intestinal barrier function.

Conditions

Gastrointestinal Tract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Wec120B group

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Probiotic strips with different strain formulas, Specification: 2g/bag. Storage method: Keep away from light, seal tightly, and store in a cool, dry place.

Wec300B group

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Probiotic strips with different strain formulas, Specification: 2g/bag. Storage method: Keep away from light, seal tightly, and store in a cool, dry place.

Interventions

Probiotic

Probiotic strips with different strain formulas, Specification: 2g/bag. Storage method: Keep away from light, seal tightly, and store in a cool, dry place.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

（1）Age: 18-65; （2）It conforms to the diagnostic criteria for gastrointestinal dysfunction formulated in the "Expert Consensus on Precision Health Communication in China - Guidelines for Citizens' Intestinal Health"; （3）Symptoms: Irregular defecation, loose or hard stools; Intestinal rumbling in the abdomen Abdominal distension Hiccups, belching; Severe intestinal flatulence; Abdominal pain Acid reflux and heartburn; Pain in the stomach or abdomen when hungry; Disgusting; (4) Signs: Abdominal pain and abdominal distension; Diarrhea and constipation Indigestion Gastric acid reflux Bad breath and farting smell; Skin problems The color and shape of the stool have changed.

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Exclusion Criteria

(1)Drugs that affect the intestinal flora (including antibacterial drugs, microecological preparations, intestinal mucosal protectants, traditional Chinese patent medicines, etc.) should be used continuously for more than one week within one month before screening; （2）Recent use of products with similar functions to the test product, which may interfere with the judgment of the study results; (3) use of antibiotics during illness; (3)Use of antibiotics during illness; (4)Resence of severe systemic diseases or malignant tumors; (5)allergy to any components of the probiotics used in the study; (6)women who are pregnant, breastfeeding, or planning to conceive in the near future.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

School of Food and Bioengineering, Henan University of Science and Technology

Luoyang, Henan, China

Countries

China

Other Identifiers

WK20250616

Identifier Type: -

Identifier Source: org_study_id