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

NCT06781814 | Completed

• 1 other identifier: WK20241231
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Concentration of Short-Chain Fatty Acids in Fecal Samples

  4 weeks

• Metabolite Profile in Fecal Samples as an Indicator of Intestinal Microbiota Health

  4 weeks

Study Arms (2)

Wec600B group

EXPERIMENTAL

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

Wec1000B group

EXPERIMENTAL

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

Interventions

Probiotic 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; Wec600B 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:

• Voluntarily, in writing, sign the informed consent form, agreeing to participate in this study
• Able to complete the study according to the requirements of the trial protocol
• Age between 18 and 65 years old
• Meet the diagnostic criteria for gastrointestinal dysfunction established in the "Chinese Precision Health Communication Expert Consensus on Citizen's Guide to Gastrointestinal Health"
• 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
• 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 -

You may not qualify if:

• 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
• Short-term consumption of products similar to the test substance, which affects the judgment of the results
• Use of antibiotics during illness
• Participants with severe systemic diseases or malignant tumors
• Participants allergic to any components of the compound probiotic freeze-dried powder used in this trial
• Women who are pregnant or breastfeeding, or those who have plans to conceive in the near future
• Participants who cannot participate in the trial due to personal reasons
• Other participants deemed unsuitable for participation by the researcher -

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: January 1, 2025
• First Posted: January 17, 2025
• Study Start: July 30, 2024
• Primary Completion: June 2, 2025
• Study Completion: June 9, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

CN (1)