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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Tract
• Intervention / Treatment: Dietary supplement: Probiotic

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Luoyang, Henan, China, 471000
      • School of Food and Bioengineering, Henan University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wec120B group	Dietary supplement: 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.
Experimental: Wec300B group	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of gastrointestinal symptoms	Bowel movement frequency improvement: use the "bowel movement frequency scale"	4 weeks

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2024
• Primary Completion (Actual): June 10, 2025
• Study Completion (Actual): June 12, 2025

Study Registration Dates

• First Submitted: June 16, 2025
• First Submitted That Met QC Criteria: June 16, 2025
• First Posted (Actual): June 18, 2025

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: WK20250616

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No