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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Function
• 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. 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 -

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: 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.	Dietary supplement: 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.
Experimental: 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.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of gastrointestinal function in study participants	Bowel movement frequency improvement: use the "bowel movement frequency scale" to record the number of bowel movements per week for participants, in order to assess changes in bowel movement frequency.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Short-Chain Fatty Acids in Fecal Samples	The concentration of short-chain fatty acids in fecal samples was determined by gas chromatography-mass spectrometry (GC-MS).	4 weeks
Metabolite Profile in Fecal Samples as an Indicator of Intestinal Microbiota Health	The metabolites in fecal samples were detected by liquid chromatography-mass spectrometry (LC-MS).	4 weeks

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Actual): June 2, 2025
• Study Completion (Actual): June 9, 2025

Study Registration Dates

• First Submitted: January 1, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): January 17, 2025

Study Record Updates

• Last Update Posted (Actual): June 19, 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: WK20241231

Drug and device information, study documents

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