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

NCT07025798 | Completed

• 1 other identifier: WK20250616
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Improvement of gastrointestinal symptoms

  Bowel movement frequency improvement: use the "bowel movement frequency scale"

  4 weeks

Study Arms (2)

Wec120B group

EXPERIMENTAL

Dietary Supplement: Probiotic

Wec300B group

EXPERIMENTAL

Dietary Supplement: Probiotic

Interventions

Probiotic 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.

Wec120B group; Wec300B 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:

• （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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

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

Luoyang, Henan, 471000, China

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

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: June 16, 2025
• First Posted: June 18, 2025
• Study Start: August 30, 2024
• Primary Completion: June 10, 2025
• Study Completion: June 12, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

CN (1)