Research on the Role of Compound Probiotic Freeze-dried Powder in Improving Gastrointestinal Function

NCT ID: NCT06781814

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-30
• Study Completion Date: 2025-06-09

Brief Summary

This study aims to evaluate the effect of four high-activity compound probiotic freeze-dried powders on improving gastrointestinal function, observing their regulatory effects on the gut microbiota and the incidence of adverse reactions in study participants over a 4-week intervention period.

Conditions

Gastrointestinal Function

Study Design

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

Study Groups

Wec600B group

Participants will take the probiotic freeze-dried powder daily, each serving being 3.0 grams, to be consumed half an hour after meals.

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Probiotic strips with different strain formulas, specification: 3g/bag. Storage method: Keep away from light, seal tightly, and store in a cool, dry place.

Wec1000B group

Participants will take the probiotic freeze-dried powder daily, each serving being 3.0 grams, to be consumed half an hour after meals.

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Probiotic strips with different strain formulas, specification: 3g/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: 3g/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. Voluntarily, in writing, sign the informed consent form, agreeing to participate in this study

2. Able to complete the study according to the requirements of the trial protocol

3. Age between 18 and 65 years old

4. Meet the diagnostic criteria for gastrointestinal dysfunction established in the "Chinese Precision Health Communication Expert Consensus on Citizen's Guide to Gastrointestinal Health"

5. Symptoms: Irregular bowel movements, loose or hard stools, abdominal bloating, belching, flatulence, severe intestinal gas, abdominal pain, acid reflux, heartburn, pain in the stomach or abdomen when hungry, nausea

6. Signs: Abdominal pain and bloating, diarrhea and constipation, indigestion, gastric acid reflux, bad breath and foul-smelling flatulence, skin problems, changes in stool color and shape -

Exclusion Criteria

1. Use of drugs affecting the intestinal flora (including antimicrobials, probiotics, intestinal mucosal protective agents, traditional Chinese patent medicines, etc.) for more than 1 week continuously within 1 month prior to screening

2. Short-term consumption of products similar to the test substance, which affects the judgment of the results

3. Use of antibiotics during illness

4. Participants with severe systemic diseases or malignant tumors

5. Participants allergic to any components of the compound probiotic freeze-dried powder used in this trial

6. Women who are pregnant or breastfeeding, or those who have plans to conceive in the near future

7. Participants who cannot participate in the trial due to personal reasons

8. Other participants deemed unsuitable for participation by the researcher -

• 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

WK20241231

Identifier Type: -

Identifier Source: org_study_id