NCT07025798CompletedNot Applicable
The Impact of Compound Probiotic Freeze-dried Powder on Enhancing Gastrointestinal Health
Wecare Probiotics Co., Ltd.1 site in 1 country100 target enrollmentStarted: August 30, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Wecare Probiotics Co., Ltd.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Improvement of gastrointestinal symptoms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
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.
Arms & Interventions
Wec300B group
Experimental
Intervention: Probiotic (Dietary Supplement)
Wec120B group
Experimental
Intervention: Probiotic (Dietary Supplement)
Outcomes
Primary Outcomes
Improvement of gastrointestinal symptoms
Time Frame: 4 weeks
Bowel movement frequency improvement: use the "bowel movement frequency scale"
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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